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Ghadiany, M., Rahimi, H., Rezvani, H., Mohammad Alizadeh, A., Zamani, N., Mehdizadeh, M., & Foratyazdi, M. (2016). Prophylaxis of neutropenic fever with ciprofloxacin in patients with acute myeloid leukemia treated with intensive chemotherapy. Asia-Pacific Journal of Clinical Oncology, 12, e11–e15.

Study Purpose

To compare outcomes between patients with acute myeloid leukemia (AML) who did or did not receive prophylactic ciprofloxacin 500 mg twice per day for neutropenic fever

Intervention Characteristics/Basic Study Process

Administration of prophylactic ciprofloxacin 500 mg twice daily for the prevention of neutropenic fever

Sample Characteristics

  • N = 69   
  • MEAN AGE = 41.3 years (SD = 14.3) ciprofloxacin group, 37.4 years (SD = 9) non-ciprofloxacin group
  • MALES: 68.1%, FEMALES: 31.9%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: AML as diagnosed by bone marrow and peripheral blood smear showing greater than 20% blasts and meeting AML criteria on flow cytometry analysis (criteria for flow cytometry indications of AML not specified)
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients native to Tehran who had been treated from September 2009 to November 2010 for AML with idarubicin 12 mg/m2/day for three days and Ara-C 100–200 mg/m2/day as a continuous infusion for seven days were included.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective, medical record, cross-sectional evaluation

Measurement Instruments/Methods

Outcome measurements included rate of neutropenic fever episodes, microbiologic findings, patterns of resistance, and mortality. Independent variables included demographic data, type of AML, and administration or absence of the intervention (prophylactic ciprofloxacin). Administration of granulocyte–colony-stimulating factors were also included in the analyses.

Results

No statistically significant differences were found in any of the outcome variables between patients who received prophylactic ciprofloxacin compared to patients who did not receive the prophylactic treatment. Specifically 80% of the treatment group and 82% of the control had neutropenic fevers. Although mortality rates were lower among those who received the prophylactic ciprofloxacin compared to those who did not, the differences were not statistically significant.

Conclusions

There is no benefit of prophylactic ciprofloxacin for the prevention of neutropenic fever among patients undergoing induction chemotherapy for AML. These findings aligned with other similar studies with the exception of one that the researchers found in the literature.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable

Nursing Implications

Understanding the ineffectiveness of prophylactic ciprofloxacin for the prevention of febrile neutropenia in patients undergoing induction chemotherapy for AML can aid in treatment decisions and promote the use of more effective interventions.

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Gewandter, J.S., Mohile, S.G., Heckler, C.E., Ryan, J.L., Kirshner, J.J., Flynn, P.J., . . . Morrow, G.R. (2014). A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): A University of Rochester CCOP study of 462 cancer survivors. Supportive Care in Cancer, 22, 1807–1814.

Study Purpose

To determine the effectiveness and safety of the topical application of a combined 2% ketamine and 4% amitriptyline (KA) cream for reduction of chemotherapy-induced peripheral neuropathy (CIPN) in patients who have completed chemotherapy

Intervention Characteristics/Basic Study Process

One week prior to enrollment, subjects completed a seven-day daily pain, numbness, and tingling diary over the past 24 hours. Subjects answered the question for any of the three symptoms in either their hands or feet. At enrollment, subjects were instructed to use a measuring device for application of 4 g of either KA or placebo cream twice daily to each area of hands or feet with any pain, numbness, or tingling. The seven-day daily pain, numbness, and tingling diary for pain over the past 24 hours, by numeric rating scale (NRS), was completed at three and six weeks after enrollment. A secondary analysis for pain using NRS was done at baseline, three, and six weeks.

Sample Characteristics

  • N = 458
  • AGE = 18 years or older; range not defined
  • MALES: 29%, FEMALES: 71%
  • KEY DISEASE CHARACTERISTICS: 40% breast cancer, 27% gastrointestinal cancer, 9% hematologic malignancy, 3% head and neck cancer, 8% lung cancer, 7% gynecologic cancer, 5% genitourinary cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: 100% had previous chemotherapy, 85% had previous surgery, 48% had previous radiation therapy, and 53% had prior taxanes; no statistical difference in sample characteristics between groups
  • INCLUSION: One month post-completion of chemotherapy; subjects with average seven-day pain, numbness, and tingling ratings of greater than 4; 18 years or older; KPS greater than 60; pain medications allowed if the dose was stable for two weeks prior to enrollment
  • EXCLUSION: Pre-existing peripheral neuropathy resulting from something other than chemotherapy; prior neurologic procedures or topical treatment; clinical depression; medications: monoamine oxidase inhibitors, barbiturates, anticholinergic agents, sympathomimetic drugs, inhibitors CP450 2D6; open skin lesions in the region of cream application; creatinine greater than 2 mg/dL within 30 days prior to screening

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Outpatient    
  • LOCATION: University of Rochester Cancer Center Community Clinical Oncology Program

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment 
  • APPLICATIONS:  Elder care, palliative care

Study Design

  • Multi-center, phase III, double-blind, randomized, placebo-controlled clinical trial
    • Stratified into two treatment regimen groups: prior taxanes and nontaxane

Measurement Instruments/Methods

  • NRS (0 = not at all to 10 = as bad as you could imagine) for evaluation of any pain, numbness, and tingling in hands or feet
  • Secondary analysis for pain in hands or feet was evaluated with an NRS  (0 = no pain to 10 = worst pain you can imagine) adapted from the MD Anderson Symptom Inventory.

Results

No therapeutic effect was observed with the application of KA cream to the affected areas on hands or feet for reduction of pain, numbness, and tingling (p = 0.363). Secondary analysis for pain alone did not show a statistically significant difference between groups comparing means at 95% CI (KA cream, 4.64; placebo, 4.68). Patients in the treatment regimen group of prior taxanes, regardless of receiving study treatment with either KA or placebo, reported a reduction in pain, numbness, and tingling at six weeks (p = 0.042). No statistically significant adverse events were reported for the KA treatment group compared to the placebo group.

Conclusions

This study showed no therapeutic benefit for the topical application of KA cream for CIPN.

Limitations

  • Measurement validity/reliability questionable
  • No separation for measurement of pain, numbness, or tingling in the primary analysis
  • No standardized scale for symptom assessment of peripheral neuropathy was used (i.e., National Cancer Institute Common Toxicity Criteria) in the primary analysis
  • Other limitations/explanation: Unknown type of prior chemotherapy for sample population other than taxanes; unknown surgical and radiation therapy anatomic sites; unknown patient sample age range and comorbidities

Nursing Implications

Further studies need to be done to investigate if any combination or separate topical compound targeting specific nociceptive pathways has a therapeutic benefit for CIPN.

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Gergich, N.L.S., Pfalzer, L.A., McGarvey, C., Springer, B., Gerber, L.H., & Soballe, P. (2008). Preoperative assessment enables the early diagnosisand successful treatment of lymphedema, Cancer 112, 2809–2819.

Study Purpose

To investigate the efficacy of a surveillance method for the diagnosis and management of subclinical lymphedema in patients with early-stage breast cancer

Intervention Characteristics/Basic Study Process

Diagnostic criteria for lymphedema included a volume increase of 3% in the affected upper limb compared with the patient’s preoperative measurement and with consideration of the contralateral limb volume changes. When lymphedema was diagnosed, garments were prescribed for daily wear. No activity limitations were placed for the duration of the intervention. At follow-up, when limb volume decreased, women were advised to continue wearing the garment only when completing strenuous exercise or activity, during air travel, with symptoms of heaviness, or if visible swelling appeared. Time points of evaluation were the preoperative visit and 1, 3, 6, 9, 12, and 18 months postoperatively.

Sample Characteristics

  • The study sample (N = 86) was comprised of a subclinical lymphedema (n = 43) group and control group (n = 43).
  • Mean age was 55.3 and 53.4 years for the subclinical lymphedema and control groups, respectively. 
  • All patients were female with newly diagnosed, unilateral, early-stage breast cancer (stage I–III).
  • Patients were excluded if they had a previous history of breast cancer, bilateral breast cancer, or severe trauma or surgery of the affected upper limb.

Setting

The study took place at the National Naval Medical Center Breast Care Center in Bethesda, MD.

Study Design

The study used a case-control design.

Measurement Instruments/Methods

  • Measurements for both upper limbs were taken using a Perometer.
  • Upper-limb volume was calculated by using 80% of the total limb length, which was measured from the ulnar styloid process to the tip of the acromion for standardization.
  • Body weight was recorded at each visit to control for weight change.

Results

The time to onset of lymphedema averaged 6.9 months postoperatively. The subclinical lymphedema group had significantly higher upper-limb volume than the control group when the compression intervention was introduced. After the intervention, a statistically significant mean 48 ml volume decrease was realized (p < 0.0001) in the subclinical lymphedema group with activity-related garment wear only compared with 2.3 ml decrease in the control group. The mean duration of the intervention was 4.4 weeks. Volume reduction was maintained at an average follow-up of 4.8 months after the intervention.

Conclusions

Preoperative assessment in the context of a prospective surveillance model enables the early detection and management of subclinical lymphedema. An early intervention protocol reduces the affected limb volume to near baseline measures and prevents progression to a more advanced stage of lymphedema for at least the first year postoperatively.

Limitations

The study does not use a randomized controlled design.

Nursing Implications

Preoperative baseline measurement is vital to successfully diagnosing subclinical lymphedema. However, currently, physical therapists in clinical practice rely on an impairment-based model for diagnosing and treating lymphedema. The paradigm is inadequate and a shift in the current practice pattern in favor of surveillance models is necessary. Further research is warranted to confirm the long-term clinical and cost effectiveness of this surveillance model compared with a traditional impairment-based model in treating breast cancer-related lymphedema.

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Gerber, P.A., Meller, S., Eames, T., Buhren, B.A., Schrumpf, H., Hetzer, S., ... Homey, B. (2012). Management of EGFR-inhibitor associated rash: A retrospective study in 49 patients. European Journal of Medical Research, 17(1), 4.  

Study Purpose

To compare the effectiveness of three established rash-management strategies in EGFR-inhibitor (EGFRI) associated rash development

Intervention Characteristics/Basic Study Process

Rash severity was assessed during the initial presentation to clinic by applying the EGFR-Induced Rash Severity Score (ERSS). Three different EGFRI rash-management strategies were compared, and each targeted the inflammatory and/or the infectious characteristics of the rash. In stage 1 of the study, 21 patients (ERSS 10.3 to 77.9) were treated topically with mometasone furoate cream (a topical anti-inflammatory) twice daily. In stage 2 of the study, 23 patients (ERSS 12.5 to 67.1)  were treated topically with nadifloxacin 1% cream (a potent topical fluoroquinolone antibiotic) once daily in the morning, in combination with prednicarbate 0.25% cream (a topical glucocorticosteroid) once daily in the evening. In stage 3 of the study, five patients (ERSS > 50) received topical nadifloxacin and prednicarbate 0.25% cream in combination with the systemic retinoid isotretinoin 10–20 mg/day. Rash severity was reassessed after three weeks of specific therapy to manage the dermatologic reaction.

Sample Characteristics

  • N = 49            
  • AGE = Not reported
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: Not reported
  • OTHER KEY SAMPLE CHARACTERISTICS: (1) DRUG: Patients who were treated with either cetuximab (a monoclonal anti-EGFR antibody) or erlotinib (a small molecule EGFR tyrosine kinase inhibitor), and who developed an EGFRI-associated rash at the time of referral to the physician’s clinic. (2) TIMING: Selection was limited to initial patients, and their follow-up visits were made in the timeframe of March 2007 to October 2009. (3) RASH SEVERITY: Patients who presented with ERSS of 10 or higher.  

Setting

  • SITE: Multi-site      
  • SETTING TYPE: Outpatient          
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective, uncontrolled, comparative study

Measurement Instruments/Methods

The EGFR-induced rash severity score (ERSS or WoMoScore) is a skin-specific scoring system that was introduced in 2008. The ERSS is a combined score of the severity of five different aspects of the EGFRI rash (i.e., color of erythema, distribution of erythema, population, postulation, and scaling crusts), and the extent of affected facial area and the total body area involved.  
 
ERSS score ranges are 0 (no skin reaction), 1–20 (mild), 21–40 (moderate), and more than 40 (severe). Rash severity was assessed during initial presentation to the clinic and at three weeks of specific therapy to manage the dermatologic reaction. Statistical analysis was performed using the Student’s t-test.   

Results

Patients' EGFRI-associated rash severity improved significantly with all three dermatological treatments, which are aligned with recent expert recommendations: topical mometasone furoate cream (p = 0.00009); nadifloxacin 1% cream and prednicarbate 0.25% cream (p = 0.03); and nadifloxacin 1% cream and prednicarbate 0.25% cream plus systemic isotretinoin (p = 0.015).

Conclusions

In summary, the results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions, including topical glucocorticosteroids, topical antiseptics/antibiotics, and systemic retinoids. Topical mometasone furoate cream was the only therapy that resulted in a complete resolution of all rash symptoms in one patient.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)  
  • Risk of bias (no random assignment)
  • Other limitations/explanation
    • For the sample population, age, sex, and diagnosis were not reported.
    • Statistical comparison of different therapy regimens is limited due to variations in patient numbers and rash severity in each of the three test groups before therapy. Specifically, group 3 had only five patients and the rash severity in all five patients was ERSS > 50 (severe).
    • The study design did not include a control group, which would have been a subgroup of patients with EGFRI rash that was left untreated for the study period (three weeks).
    • In the abstract, the authors state that mild to moderate rashes should be treated with basic measures in combination with other dermatologic treatments. In the discussion section, the authors state, “Notably, all approaches that were analyzed in this study are in line with recent expert recommendations that suggest an escalating strategy for the management of the EGFRI rash with a succession of treatments, as indicated, summarized as follows: intensive skin care in combination with mild cleansers ... .”   The components of “basic measures” or “intensive skin care” were not described, and whether intensive skin care and mild cleansers were included with the other interventions is not delineated in the article.
    • The ERSS system was designed with a non-linear affected area scale emphasizing minor variations in mild patients with face involvement only.   

Nursing Implications

Nurses should consider treating mild to moderate EGFRI skin rashes with basic skin care measures in combination with topical glucocorticosteroids or combined regimens using glucocorticosteroids and antiseptics/antibiotics. Nurses should be aware that more severe or therapy-resistant rashes may respond with the addition of systemic retinoids.

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Gerber, B., Koppel, J., Paul, M., Nguyen-Kim, T.D., Frauenfelder, T., Nair, G., . . . Manz, M.G. (2014). Efficacy of anti-fungal but not anti-bacterial prophylaxis in intensive primary AML therapy: a real-world, retrospective comparative single-centre study. Swiss Medical Weekly, 144, w13985. 

Study Purpose

To assess the effect of primary prophylaxis with posaconazole and levofloxacin on the incidence of invasive fungal infections (IFI) and bacteremia

Intervention Characteristics/Basic Study Process

This was a retrospective, single-center study that evaluated two groups of adult patients with acute myeloid leukemia/acute promyelocytic leukemia (AML/APL) and high-grade myelodysplastic syndrome (MDS) receiving intensive chemotherapy. The primary endpoint was IFI and bacteremia with secondary endpoints of overall survival at day 100 and at two years, time from the initiation of chemotherapy to the onset of IFI, the use of intravenous and oral antifungal and antibacterial therapy, and total duration of antifungal and antibacterial medication.

Sample Characteristics

  • N = 88 (43 no prophylaxis and 45 prophylaxis)
  • AVERAGE AGE = 49.8 years (no prophylaxis); 53.5 years (prophylaxis)
  • MALES: 51.2% (no prophylaxis); 51.1% (prophylaxis)
  • KEY DISEASE CHARACTERISTICS: Patients with AML, APL, or high-grade MDS receiving intensive chemotherapy

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University Hospital Zurich

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective 

Measurement Instruments/Methods

  • Radiologic diagnosis of IFI determined by two independent evaluators
  • Possible or proven IFI defined according to European Organisation for Research and Treatment of Cancer and ​Mycoses Study Group (EORTC/MSG) criteria

Results

IFIs were significantly less common in the prophylaxis group after the first chemotherapy cycle (33.3% versus 65.8%; p = 0.0088). IFIs were significantly less common in the prophylaxis group after the last chemotherapy cycle (53.9% versus 88.9%; p = 0.0021). Chemotherapy cycles that were complicated with bacteremia occurred at a rate of 34.6% with prophylaxis and 32.3% in the nonprophylaxis group; p = 0.8. Positive blood cultures were 50 and 43, respectively, with a nonsignificant trend to more gram-negative infections in the nonprophylaxis group (42% versus 14%; p = 0.073) and to more gram-positive infection in the prophylaxis group (86% versus 58%; p = 0.092). Overall survival at 100 days and at two years, as well as the use of antiviral medications, did not differ between the two arms. Fewer fever days (5.6 versus 9.2;  p = 0.00032) and less cytarabine toxicity (18.3% versus 35%; p = 0.025) were observed in the prophylaxis arm.

Conclusions

This single-center retrospective study of posaconazole prophylaxis was efficient in reducing the possible IFIs with a number needed to treat to prevent one IFI of only three. This institution had a relatively high rate of IFIs when compared to published data. Posaconazole for prophylaxis was cost-effective. There was no benefit seen in the use of levofloxacin in preventing bacteremia.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described
  • Findings not generalizable
  • Other limitations/explanation: The rate of IFIs in this institution was higher compared to other published data, and the inclusion of possible IFIs may have led to an overdiagnosis of IFIs, which might not reflect the true outcomes of IFI.

Nursing Implications

Oncology nurses should be aware of facility policies relating to the use of prophylaxis for IFI and bacteremia and should understand the local climate that may affect the rate of IFIs. This facility used posaconazole and levofloxacin as prophylaxis agents. Other agents exist and are currently in use that may produce different outcomes.

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Gerber, G.S., Zagaja, G.P., Ray, P.S., & Rukstalis, D.B. (2000). Transdermal estrogen in the treatment of hot flushes in men with prostate cancer. Urology, 55, 97–101.

Study Purpose

The study evaluated the efficacy of transdermal estrogen in men in moderating hot flashes after hormonal therapy for prostate cancer.

Intervention Characteristics/Basic Study Process

  • Intervention: Estrogen patch
    • Low dose (0.05 mg)
    • High dose (0.5 mg)
  • Description of protocol:
    • Daily log maintained
    • Participants randomized to low-dose or high-dose of transdermal estrogen, then switched after four week washout to other dose

Sample Characteristics

The study enrolled 12 men with advanced prostate cancer who were receiving leuprolide injections every one or three months. They were experiencing at least three hot flush episodes daily for at least three months.

Study Design

This was a randomized, multi-dose, crossover trial.

Measurement Instruments/Methods

Treatment response was assessed indaily logs. Questionnaires were completed every four weeks, including visual analog assessment. Serum luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, and estradiol levels were taken every four weeks.

Results

Key outcomes of the study included:

  • Significant reduction in overall severity of hot flushes with both the low-dose and high-dose patches in 10 of the 12 men (83%) 
  • Significant decrease in daily frequency of hot flushes with high-dose patch 
  • Overall moderate to major improvement in symptoms at both doses (p = 0.04)
  • FSH levels decreased significantly with both doses; estradiol levels increased with both doses. No significant change in serum testosterone or LH.

Limitations

Study limitations included small sample size, absence of placebo arm, short duration.

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Gentili, M., Clerico, M., Spizzichino, M., & Fanelli, G. (2016). Use of a checklist to improve pain control in hospitalized cancer patients: The 38Checkpain project. Future Oncology, 12, 199–205. 

Study Purpose

To evaluate whether use of a checklist dedicated to pain management-related practices would improve pain control in inpatient settings

Intervention Characteristics/Basic Study Process

A checklist (38Checkpain) was developed by a group of patient management experts identifying practices related to pain management outlined in Italian law. The checklist consisted of seven items to remind practitioners of correct steps for assessment, monitoring, management, and treatment of pain. Healthcare centers participating in the program collected information on these aspects of pain management, adverse of effects, and episodes of breakthrough pain for all patients hospitalized that day on the unit for seven days. After, healthcare centers were randomized to use the checklist or to continue current practice without use of the checklist. Checklist items were measuring intensity of pain, checking if pain was 3 or less, modifying therapy if pain intensity was greater than 3, assessing the presence of adverse events with pain treatment, setting a specific therapy of adverse event management, checking for presence of factors that increase acute pain, and setting a specific therapy for treatment of factors that cause acute pain. The checklist was applied in patients with pain twice daily by providers. Data were collected for 21 days.

Sample Characteristics

  • N = 92 organizations, 895 patients   
  • AGE: Not provided
  • MALES: Not provided, FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: Not provided

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Italy

Study Design

  • Prospective, randomized cohort

Measurement Instruments/Methods

  • 1–10 numeric pain rating scale 
  • Proportion of patients with controlled pain, defined as intensity of 3 or less on numeric scale
  • Incidence of adverse events
  • Number and severity of breakthrough pain episodes

Results

Mean pain intensity declined in the checklist group over the study period from 3.8–2.7. Mean pain intensity did not decline steadily in the no checklist group and overall was consistently higher. The proportion of patients with effective control of pain increased from 20.1% to 67.6% in the checklist group. In the no checklist group, control of pain increased by 13.8%. The incidence of breakthrough pain episodes decreased by 21.4% in the checklist group but increased by 6.6% in the other group. Compliance with checklist use was reported as at least once daily.

Conclusions

The use of a checklist to remind healthcare providers to make specific assessments and intervention plans for patients with pain appeared helpful in improving overall pain-related patient outcomes.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement validity/reliability questionable
  • Very little information to describe the patients is provided. 
  • No statistical analysis was done. 
  • The control group was about half the number of sites as the checklist cohort.
  • Patients of whom data were collected from week to week were different patients, so it is unclear if outcomes differed based on the intervention examined here or on other patient conditions.

Nursing Implications

This study has multiple limitations; however, it does suggest that at least daily use of a checklist reminder for assessment and intervention practices for patients with pain may improve overall pain management and related patient outcomes. Checklists have been used in multiple ways in health care and may be an effective tool in reminding practices to improve various types of patient outcomes.

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Genot-Klastersky, M.T., Klastersky, J., Awada, F., Awada, A., Crombez, P., Martinez, M.D., et al. (2008). The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: Results from two prospective studies. Supportive Care and Cancer, 16(12), 1381–1387.

Intervention Characteristics/Basic Study Process

100 mW laser was delivered to tissues with a 1.2 mm spot size. Treatment areas included inferior and superior lips, right and left cheeks, right and left tongue, palate and velum palate, right and left gums, and tongue frenulum.

Average energy was 2 J/cm2 on all sites, with a calculated mean duration of 33 seconds per site; each treatment lasted six minutes.

  1. Three sessions per week
  2. Started within 24 hours of diagnosis and given every other work day

Sample Characteristics

(1) Patients with various solid tumors treated with chemotherapy; previous oral mucositis of 2 or higher

26 patients for 90% power

Patients with concomitant RT and those \"expected to be poor compliers to the treatment schedule\" were excluded.

Mean age 51 was years (range = 32–73 years).
20 women; 6 men

 

(2) Randomized trial for patients with hematologic malignancies who developed mucositis receiving radiochemotherapy prior to HSCT. Therapy started 24 hours after diagnosis of mucositis. Sham laser control was used.
20 patients were needed in each arm for 90% power.

n = 36 (18 patients in each arm)
 

Measurement Instruments/Methods

Grade of mucositis using EORTC scale

Grading was performed by a nurse prior to each treatment session and afterward once a week by an independent blinded professional observer.

All treated areas were examined.
 

Results

1. 21 of 26 patients were considered to have prevented mucositis (81%, 95% CI = 61%–93%); 4 with no mucositis, and 17 with grade I. Five patients had grade 2 or higher; median duration was 10 days (range = 8–14 days).

2. Grade 3 mucositis was observed in 16 patients in the sham group and in 3 LEL treated patients (p = 0.001). Overall success rate was 15 of 18 (83%, 95% CI = 59%–96%) and 2 of 18 in the control group (11%, 95% CI = 1–35).Time to grade 3 mucositis was calculated (p < 0.0001).

Of 16 patients in the control arm who developed grade 3–4, eight later received laser treatment; regression to grade 1 mucositis was three days in this group and four days in those who did not receive LEL.
 

Limitations

Limited sample size, although the prevention trial (1) achieved 90% power.

The heterogeneous population in the prevention trial makes the results difficult to generalize. Oral care and other factors were not reported.

 

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Gennaro, P., Gabriele, G., Mihara, M., Kikuchi, K., Salini, C., Aboh, I., . . . Ungari, C. (2016). Supramicrosurgical lymphatico-venular anastomosis (LVA) in treating lymphoedema: 36-months preliminary report. European Review for Medical and Pharmacological Sciences, 20, 4642–4653. 

Study Purpose

To evaluate the effects of lymphaticovenular anastomosis (LVA) on patients with lymphedema

Intervention Characteristics/Basic Study Process

A retrospective research study of 36-months of follow-up of 69 patients with lymphedema after LVA surgery. Each had a preoperative ultrasound with an echo-color doppler. Results were not discussed in the study, neither did it state why these were done.
 
Each patient was measured bilaterally with 5 circumferential measurement points. Sums were compared pre- and postoperatively and then at multiple intervals throughout 36 months.
Upper extremity: hand, wrist, elbow, 5 cm distal and 5 cm proximal to the elbow
Lower extremity: dorsum of the foot, ankle, the knee, 10 cm distal and 10 cm proximal to the knee
 
Pre- and postoperative indocyanine green dye (ICG) lymphography: Each patient had an ICG lymphography, which is injected into the distal extremity, involving an infrared light issues to visualize the lymphatics. After the intervention, patients evaluated their quality of life and lymphedema. They were evaluated again at two weeks, one month, and every six months after surgery. Patients started lymph drainage postoperatively. Patients wore compression for one year after the surgery.

Sample Characteristics

  • N = 69   
  • MEAN AGE = 55 years (range = 16–76 years)
  • MALES: 7%, FEMALES: 93%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Unilateral upper or lower extremity lymphedema with or without a history of cancer diagnosis; of the 69 patients, 42 had upper extremity lymphedema and 27 had lower extremity edema; of the patients with cancer, 40 had a history of breast cancer, 9 had a history of endometial cancer, 3 had a history of melanoma with lymphadenectomy, 2 a history of ovarian cancer, 2 had cervical cancer, 1 had sarcoma, and 1 had bladder cancer with lymphadenectomy; 9 patients had primary lymphedema, and 1 had traumatic lymphedema; of the patients with cancer, 39 had radiation therapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with at least a one-year follow-up were included in the study.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: Italy

Phase of Care and Clinical Applications

APPLICATIONS: Pediatrics, elder care

Study Design

Retrospective

Measurement Instruments/Methods

Measuring tape

Results

All patients lost volume with an average reduction of 50%. None of the study patients reported an event of cellulitis during the follow-up. Patients with histories of cellulitis had less reduction. A 49% reduction was seen in patients who had reported one to two events, and a 33% reduction was seen in those with more than two events.  
  • Postoperative ICG: Three hundred thirty-seven of the 366 anastomosis remained patent. 
  • Subjective reporting: Sixty-seven reported satisfaction: lighter limbs, softer tissue, less pain, and improved function.

Conclusions

The LVA appears to successfully establish alternate lymphatic drainage pathways in the lymph damaged limb. It is minimally invasive requiring considerably less surgery than the lymph node transplantation procedures and potentially better outcomes. The patients tolerate it well and recovery quickly. It is unclear whether patients no longer needed to use compression garments, but the study reported that all had a reduction in compression class. The researchers reported outcomes that did reflect disease progression: Stage IV limbs did not improve, as well as stage II.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

Nursing Implications

The findings suggest that LVA may be helpful for patients to reduce lymphedema. Nurses need to be aware of patient education needs if this procedure is used.

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Gennaro, M., Maccauro, M., Sigari, C., Casalini, P., Bedodi, L., Conti, A. R., . . . Bombardieri, E. (2013). Selective axillary dissection after axillary reverse mapping to prevent breast cancer–related lymphoedema. European Journal of Surgical Oncology, 39, 1341–1345.

Study Purpose

To assess the occurrence of breast cancer–related lymphedema (BCRL) and the feasibility of selective axillary dissection (SAD) after axillary reverse mapping (ARM)

Intervention Characteristics/Basic Study Process

ARM was performed on 60 patients undergoing SAD. Patients received follow-up after 6–36 months and were assessed for BCRL.

Sample Characteristics

  • N = 60    
  • KEY DISEASE CHARACTERISTICS: Patients with axillary nodal involvement, diagnosed by positive sentinel lymph node biopsy or preoperative needle biopsy, scheduled for axillary lymph node dissection 
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients received three intradermal injections of Tc-labeled nanocolloid, and lymphoscintigraphy was performed one hour later. Operations were completed by the same surgeon, and SAD was completed up to Berg’s level III, with identification and preservation of the arm’s lymphatic hot spot when feasible.

Setting

  • SITE: Single site 
  • SETTING TYPE: Inpatient 
  • LOCATION: Milan, Italy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

The intervention group participated in the SAD intervention, and the control group usually had axillary lymph node dissection. 

Measurement Instruments/Methods

  • T test
  • Chi-square
  • Fisher’s exact test

Results

SAD was successful in 45 of 60 patients. Four of 45 patients in the intervention group and five of 15 patients in the control group developed lymphedema (p = .072). 

Conclusions

BCRL with SAD technique after median follow-up of 16 months had 33% the rate of lymphedema occurence than conventional ALND. SAD technique requires a separate surgery from sentinel lymph node biopsy. Authors concede there may be a learning curve to this technique, and further research is needed to determine appropriate patient selection.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Other limitations/explanation:  Relatively short follow-up to determine development of BCRL

Nursing Implications

New surgical techniques may result in lowering patient morbidity but does not eliminate the possibility of patients developing BCRL. Education should continue to be provided to all patients regarding early identification of signs and symptoms of BCRL.

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