To examine the feasibility (recruitment, retention, and adherence), preliminary efficacy, and safety of a 12-week, home-based exercise program for middle-aged and older acute myeloid leukemia (AML) survivors

• N = 40  
• AVERAGE AGE = 56 years
• MALES: 45%, FEMALES: 55%
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia; the average time from diagnosis to study enrollment for all participants was approximately two years.
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were mostly white. The mean body mass index (BMI) 28.25%. Patients had undergone posthematopoietic stem cell transplant.

• SITE: Single-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Home and “health care” gym

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

Phase II randomized controlled trial with an exercise group and a wait-list control group that could cross over to the exercise group at week 12.

• Primary outcome measures included both global quality of life (QOL) and fatigue.
• QOL was measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).  
• Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
• Secondary outcome measures included the Edmonton Symptom Assessment Scale (ESAS).

Recruitment and retention rates were 31% and 91%, respectively. The adherence rate was 28%. The analyses did not suggest statistically significant or clinically important benefits in QOL, fatigue, or physical fitness between groups. There were no adverse events.

Successful recruitment with low adherence and limited effects on clinical outcomes including fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement/methods not well described
• Other limitations/explanation: The description of the cross-over of patients from the control group is confusing and inconsistently described from the actual protocol.

Further study is needed in this population including how to enhance exercise adherence.

To evaluate the effectiveness of colloidal oatmeal lotion (Aveeno^®), administered TID for at least seven days.

• The study reported on a sample of 10 patients.
• Patients were receiving epidermal growth factor receptor–inhibitor (EGFRI) and tyrosine-kinase inhibitor (TKI) therapy (e.g., cetuximab, erlotinib, panitumumab, sorafenib) and were experiencing cutaneous reactions.

Multiple centers in Washington, DC, and New York, NY

This was an open-label study used to evaluate the rate and quality of response to colloidal oatmeal lotion.

Toxicity was graded as follows.

• Grade 1: asymptomatic, erythematous rash
• Grade 2: rash plus itching
• Grade 3: confluent lesions and tenderness
• Grade 4: deep ulcerations and exfoliative or severe xerosis

• Ten of 11 patients were evaluable.
• Six patients had a complete response and four had a partial response; therefore, the response rate was 100%.
• Responses occurred from six to 10 days after initiation of colloidal oatmeal lotion.

Treatment with colloidal oatmeal lotion appeared to be effective in controlling rash associated with EGFRIs and multiple TKIs. This treatment allowed for the continuation of antineoplastic therapy.

• This was a small, nonrandomized, open-label study.
• The description of the measurement tool or method used to grade rash symptoms was inadequate; reliability and validity were unclear.

To evaluate the short- and long-term effects of ropivacaine wound infiltration on pain after breast cancer surgery

Patients were randomized to receive, prior to surgery, either ropivacaine or normal saline placebo wound infusion. All patients received the same general anesthesia regimen of propofol and sufentanil. At the end of surgery, before skin suturing, the wound was completely infiltrated along the subcutanous and deep layers of the breast and axilla surgical incisions. Infiltration was also done in the second and third intercostal spaces. The ropivacaine group received 3 mg/kg of 0.375% ropivacaine. Pain was assessed every 30 minutes for two hours in the postanesthesia care unit and every six hours for the next 48 hours. Patients completed study questionnaires at baseline and at 3, 6, and 12 months after surgery.

• The sample was composed of 236 patients.
• Mean patient age was 56.5 years.
• All patients were female.
• All patients were undergoing surgery for breast cancer; 45%–52% had breast-conserving surgery with axillary node dissection, and 40%–45% had mastectomy with either axillary or sentinel lymph node dissection.

• Single site
• Multiple settings
• France

Mutliple phases of care

Randomized double-blind placebo-controlled trial

• Visual analog scale (VAS) to assess pain
• Brief Pain Inventory
• Hospital Anxiety and Depression Scale

• During the first 90 minutes, with patients at rest and with movement, VAS pain scores were lower in the group that received ropivacaine (p < 0.001) than in the control group.
• Over the first 48 hours in the ropivacaine group, 73% reported no pain at rest and 53% reported no pain during movement. Over the first 48 hours in the control group, 53% reported no pain at rest and 48% reported no pain during movement (p < 0.001).
• In the first 48 postoperative hours, authors noted no differences between groups in regard to morphine consumption.
• At 3, 6, and 12 postoperative months, authors noted no differences between groups in regard to pain scores.

Surgical wound infusion with ropivacaine resulted in significantly lower acute postoperative pain as measured up to 48 hours after breast cancer surgery. Wound infusion had no effect on longer-term postoperative pain.

Authors did not describe chronic levels of pain at follow-up time points.

Local wound infusion resulted in significantly lower acute postoperative pain after breast cancer surgery. This study adds to the body of evidence that demonstrates the effectiveness of this approach. Nurses can advocate for this approach to help ensure that surgical patients receive effective acute pain management.

STUDY PURPOSE: To examine the efficacy of chemoprotective agents to prevent or limit neurotoxic side effects of cisplatin and related chemotherapy agents

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 20 
• TOTAL PATIENTS INCLUDED IN REVIEW = 2459
• SAMPLE RANGE ACROSS STUDIES: 18–755
• KEY SAMPLE CHARACTERISTICS: Varied tumor types receiving platinum-based chemotherapy

PHASE OF CARE: Active antitumor treatment

There is insufficient high quality evidence to show that any agent is protective against platinum-induced neuropathy. There is some suggestion that amifostine, glutathione, and calcium and magnesium may have some effect.

• Limited number of studies included
• Low sample sizes
• There were few studies per intervention, and very few studies with small sample were included in the meta-analyses.

There is insufficient evidence to show that any agent is truly effective in protecting against neurotoxic effects of platinum-based chemotherapy. There is a continued need for well designed research using appropriate objective as well as subjective measures of neuropathy.

Examine the efficacy of purported chemoprotective agents to prevent or limit neurotoxicity of cisplatin and related agents

TYPE OF STUDY: Combined systematic review and meta-analysis

DATABASES USED: Cochrane Neuromuscular Disease Group Specialized Register, Cochrane Central Register of Controlled Clinical Trials, MEDLINE, EMBASE, LILACS, and CINAHL

KEYWORDS: Extensive list provided in article appendix

INCLUSION CRITERIA: Quasi-randomized or randomized clinical trials whose participants received cisplatin (or related compounds) chemotherapy with or without a potential chemoprotectant and were evaluated zero to six months after completing chemotherapy using quantitative sensory testing (primary) or other measures, including nerve conduction studies or neurologic impairment rating using validated scales (secondary)

TOTAL REFERENCES RETRIEVED: Sixteen randomized trials were evaluated in the initial 2006 review. In the 2010 update, 11 additional randomized trials not among the 2006 review were identified.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane method of evaluation for risk of bias done by two authors and finalized by consensus

• N (studies) = 6
• SAMPLE RANGE ACROSS STUDIES: 14–242
• TOTAL PATIENTS INCLUDED IN REVIEW: 1,537 participants
• KEY SAMPLE CHARACTERISTICS: Patients who received cisplatin chemotherapy

Cisplatin is considered to have neurotoxic effects, with patients developing sensory neuropathy. Symptoms of pain, numbness, and tingling are observed mostly in the extremities from a distal to proximal distribution. The neuropathy experienced by patients may recover partially or may become permanent. Neuroprotective agents such as acetylcysteine, acetyl-L carnitine, amifostine, calcium and magnesium, growth factors, glutathione, ORG 2766, oxcarbazepine, and vitamin E have been tested. The five newly added randomized controlled trials included three chemoprotective agents not previously described in the 2006 review.

From the data examined in this updated review, inconclusive evidence exists for recommending any neuroprotective agent tested to prevent or limit the neurotoxicity of platinum chemotherapy.

While 1,537 participants were included in the 2010 update, few trials were amenable to meta-analysis. Clinical trials of neuroprotective agents are plagued by issues of study design, including small sample size, unclear randomization and blinding procedures, and lack of quantitative measures, especially conventional QST or electrophysiologic evaluation.

To determine the efficacy of sucralfate mouthwash in the prevention of oral mucositis (OM) in patients receiving fluorouracil (5-FU) chemotherapy

Patients 18 years and older receiving chemotherapy containing 5-FU and calcium folinate were randomized into two groups through a computer-generated list of random numbers. One group received sucralfate suspension mouthwash and the other group received a placebo. Both groups received 10 ml of either sucralfate or placebo mouthwash every six hours for 10 days after the last dose of chemotherapy. Patients were instructed to rinse their mouth with the suspension for at least five minutes and spit it out 30 minutes after meals to ensure prolonged exposure of the mouthwash to the mucosal membranes.

• N = 51   
• AGE = Older than 18 years
• MALES: 15 (sucrafate group), 20 (placebo group); FEMALES: 10 (sucralfate group), 6 (placebo group)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastrointestinal cancer (e.g., esophageal, colon, rectal, gastric)

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Imam Khomeini Educational Hospital, Sari, Iran

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care, palliative care 

• Double-blind, randomized controlled study

• World Health Organization (WHO) grading system for mucositis
• Visual analog scale (VAS) to grade pain intensity

A statistically significant difference in the severity of mucositis was shown between the sucrafate group and placebo group on both day 5 and day 10 (p = 0.005, p < 0.001), respectively. The severity of mucositis in the sucrafate group on day 5 and 10 was grade 0. The majority of patients in the placebo group had a mucositis severity grade 2 on day 5 and day 10. A statistically significant reduction in pain intensity was shown in the sucrafate group versus the placebo group on both day 5 and day 10 (p = 0.004, p = 0.001), respectively.

Sucralfate mouthwash may be more effective than placebo in the prophylaxis of 5-FU–induced OM. A correlation between both the reduction of pain intensity and mucositis severity was shown with the use of the sucralfate mouthwash suspension, further confirming the role of sucralfate in the prophylaxis of OM in patients receiving 5-FU chemotherapy.

• Small sample (< 100)

Sucralfate mouthwash may be effective in reducing the severity and pain intensity of OM in patients receiving 5-FU.

The objective of this study was to compare the effectiveness of bleomycin as a sclerosing agent with povidone-iodine with respect to efficacy, cost, accessibility, safety, ease of administration, and number of doses for complete response.        

Forty participants were assigned into two treatment groups of bleomycin treatment or povidone-iodine treatment via block randomization. A 28Fr. chest tube was placed in all patients at the bedside under local anesthesia with opioids given for pain. The following day, both groups had a sclerosing agent instilled in the chest tube for one hour; bleomycin at 1 mg/kg in 60 mL saline in the study group and povidone-iodine 10%, which was diluted to obtain a final concentration of 2.5% povidone-iodine in the control group. Both groups had 5 mL of 2% lidocaine solution added to the sclerosing agent. In both groups, the chest tubes were clamped for one hour and then connected to water seal. All patients were admitted to the same unit in the hospital and experienced the same post-pleurodesis respiratory and pain management protocols. The chest tube remained in place until output decreased to 200 mL; if high output persisted more than 10 days, a Heimlich valve was placed and patients were discharged from the hospital. Chest x-rays were obtained post-chest tube removal and at 30 days post-procedure to evaluate size of pleural effusions. Pain and dyspnea after drainage ratings were recorded at discharge and at 30 days post-op. 

The sample was comprised of 39 patients.

Key disease characteristics included

• Biopsy- or cytology-proven malignant pleural effusions with a variety of types of cancer
• Effusions previously treated with and showing improvement with thoracenteses but recurrent or symptomatic when entered in study.

Key sample characteristics included

• Symptomatic benefit from thoracenteses
• Chest radiograph confirming lung expansion of 90% or more after therapeutic thoracenteses
• Karnofsky performance status index greater than or equal to 70
• No one with comorbidities that would exclude them from general anesthesia
• No bleeding disorders, massive skin infiltration, or active infectious disease.
   

This single-site study was conducted in the inpatient unit at Valiasr Hospital in Tehran, Iran.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care.
   

The study was a randomized clinical trial.

• Chest tube placement, +/- Heimlich valve    
• Numeric pain scale
• Chest x-ray
• Dyspnea scale (1–10)
   

• According to author reports, the groups were equivalent in demographic variables, but this data was not visible to the reviewer.
• No significant difference was seen between groups with respect to age, duration of thoracostomy, volume of pleural effusion, dyspnea score after drainage, fever, and pleural effusion after drainage, discharge, and one month later.
• Patients in the bleomycin group had significantly lower dyspnea scores at the one-month follow-up time compared to the povidone-iodine group.
• Complete pleurodesis occurred in 79% of the bleomycin group and 75% of the povidone-iodine group, which is not a significant difference in treatment results.

• Bleomycin is more effective at long-term dyspnea management based on one-month follow-up reports.
• No differences were observed between groups based on pain score following procedure, dyspnea at discharge, or reoccurrence of pleural effusion at the one-month follow-up visit. 
• Neither method demonstrated extremely superior results and appear similar in overall effects.

• The study had a small sample size of less than 100 patients.
• Groups were not matched by age and sex.
   

When compared with povidone-iodine, bleomycin offers the advantage of being more effective for dyspnea symptoms one month post-procedure. However, both methods appear similar in terms of pain scores, dyspnea at discharge, and recurrence of pleural effusions at one-month follow-up. For patients with concerns of iodine absorption or side effects, bleomycin would be a comparable sclerosing agent.

To determine if brief guided imagery or music can reduce patient pain and anxiety during cutaneous procedures

Consecutive adults undergoing surgery for basal or squamous cell carcinoma of the face were randomized to three groups: (a) guided imagery, (b) music, or (c) control. The guided imagery patients were sent a recording of the guided imagery by mail and instructed to listen to this at least once daily starting at least four days before surgery. Those in the music group listened to music via earphones during the surgery. Patients in the other two groups also wore earphones during the surgery, but without any sound. Pain and anxiety scores were obtained before and after the procedure on the day of surgery.

• N = 155   
• MEDIAN AGE = 62.4–64.2 across study groups 
• MALES: 58%, FEMALES: 42%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All had basal or squamous cell skin cancer and were undergoing facial surgery
• OTHER KEY SAMPLE CHARACTERISTICS: No significant differences across groups in the duration of surgery

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Northwestern University Hospital

• PHASE OF CARE: Active antitumor treatment

• Single-blind randomized, controlled trial

• Visual analog scale (VAS) for pain
• State-Trait Anxiety Inventory (STAI) short form
• Heart rate
• Blood pressure

There were no significant differences in average change in pain or anxiety scores between groups.

The visual imagery and music interventions as used here had no apparent effect on perioperative pain or anxiety.

• Unintended interventions or applicable interventions were not described that would influence results.
• Measurement validity/reliability questionable
• The logic of expecting to see a decline in pain from pre-op to post-op is questionable.
• No patient education on the use of the visual imagery recording was given.
• Patient adherence to use of the visual imagery was not explored.

This study did not show an effect of music or visual imagery on perioperative pain or anxiety. The lack of effects may be associated with the ways in which the interventions were provided or in the study design—it would be expected that pain should increase postoperatively and anxiety would decline after the surgery was completed. In addition, analysis was done regarding pre- and post-symptom change rather than actual postoperative symptom levels.

To determine the feasibility of an exercise intervention among women receiving treatment for breast cancer and to examine the effects of exercise on hemoglobin (Hb) and maximum oxygen volume (VO2MAX) and their association with changes in cancer-related fatigue (CRF) and quality of life (QOL) while investigating changes in selected inflammatory markers

The intervention consisted of a supervised, progressive treadmill exercise program two to three times times per week delivered in a rehabilitation center for the duration of chemotherapy (9–12 weeks).

• N = 14  
• AGE = Aged 21 years and greater
• FEMALE: 100%
• KEY DISEASE CHARACTERISTICS: Stages I–II breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: No history of depression, arthritis, or joint pain in the prior three months; engaged in regular exercise for five days per week in past three months; other uncontrolled conditions 

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Southern California and Virginia

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care  

Random assignment with repeated measures

• Feasibility: Measured by recruitment, retention, adherence to exercise protocol, tolerance of exercise testing, and the completion of data collection
• Efficacy: Measured by Hb concentration (venous blood), VO2MAX (using the Trackmaster TM500/S^® by JAS Fitness Systems in Carrollton, TX), CRF (Piper Fatigue Scale [PFS]), QOL (Functional Assessment of Cancer Treatment - Breast [FACT-Breast]), and inflammatory markers (IL6, IL10, cortisol, and myeloperoxidase) using laboratory kits

Feasibility: The recruitment rate was 45.7%, the retention rate was 87.5%, the adherence rate was 95%–97%, and the tolerance rate was 93%.  

Efficacy: There were no differences in VO2MAX at baseline between the groups. The exercise group maintained pretreatment VO2MAX levels throughout chemotherapy, and the usual-care group showed a significant decline of as much as 6.3 ml/kg per minute that continued three to four weeks after treatment. CRF outcomes favored the exercise group, and QOL, physical well-being, and functional well-being declined significantly in both the experimental and usual-care groups.

Recruitment to exercise interventions is difficult. The type of exercise, location, and the choice of a self-lead or a supervised intervention may influence the decision to participate. Retention may be influenced by flexibility in scheduling and the allowance of make-up sessions. Exercise did not have a significant effect on CRF or QOL. Changes in the inflammatory markers favored the exercise group. Exercise may protect against a decline in VO2MAX but not Hb concentrations.

• Small sample (< 30)
• Risk of bias (no blinding)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Findings not generalizable
• Intervention expensive, impractical, or training needs

This study addressed exercise dose in terms of intensity, duration, and frequency when prescribing exercise as an intervention. The inclusion of inflammatory markers is a potential benefit that future research could use to quantify the effects of an exercise intervention.

To evaluate the effects of honey on severe oral mucositis

Patients were randomized to the honey or control group. The experimental group was given a topical application of honey before the development of mucositis. Both groups received routine oral hygiene with lidocaine, mycostatin, daktarin mouth gel, and mouthwash.

• N = 40   
• MEAN AGE = 8 years (SD = 4.2 years)
• MALES: 52.5%, FEMALES: 47.5%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Hematologic tumors were most common.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Saudi Arabia

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Open-label, randomized, controlled trial

• World Health Organization (WHO) mucositis grading
• Oral cultures

Analysis showed an absolute risk reduction for the development of grade 3–4 mucositis of 35% among those using honey (p = 0.02). Less Candida colonization (p = 0.003) and bacterial colonization (p = 0.003) were seen in the honey group.

Honey may have some benefit in the management of oral mucositis.

• Small sample (< 100)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Frequency of use of honey not clearly described
• Frequency of oral care not clearly described

There may be some benefit from the use of honey to coat oral mucosa in the management of chemotherapy-induced oral mucositis. This study had several limitations.