To evaluate the clinical efficacy of nadifloxacin and prednicarbate cream for treatment of cetuximab-induced acneiform eruptions

Patients who had acneiform eruptions of varying severity were treated with nadifloxacin 1% cream and prednicarbate 0.25% cream once daily for six weeks. Patients continued their usual use of sunscreens, cleansers, and antihistamines. The severity of eruptions was scored at baseline and after one, two, and six weeks of treatment.

• N = 29
• MEAN AGE = 64.6 years (range = 38–89 years)
• MALES: 76%, FEMALES: 24%
• KEY DISEASE CHARACTERISTICS: All patients were receiving cetuximab

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

• Open-label trial

Investigator developed skin score calculated from percentage body involvement, percentage facial involvement, and skin lesion scoring on a 3-point scale for erythema and other lesion characteristics.

A significant reduction in skin score was seen at all time points (p < .05). Subjective symptoms such as pruritus, pain, and tenderness were reported to be improved. The treatment was well tolerated. Two patients reported mild burning and erythema following application of the nadifloxacin cream.

The combination of topical quinolone and corticosteroid was effective in reducing acneiform eruptions in this group of patients.

• Small sample (< 30)
• Risk of bias (no control group) 
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Other limitations/explanation: The skin score used is well described, but validity and reliability is not clear.

The combination of topical quinolone and steroid may be helpful in treating EGFR-inhibitor associated acneiform rash. This study had several methodological limitations, so it does not provide strong support. Further research in this combination is warranted.

To assess the feasibility of recruiting and retaining cancer survivors with lower-extremity lymphedema in an exercise intervention study and to determine preliminary estimates of the safety and efficacy of the intervention
 

Patients participated in slow, progressive weight lifting two times weekly, supervised for two months, then unsupervised for three months. Participants were instructed in warm-up, stretching, breathing, weight training and additional stretching exercises by a certified fitness professional. Exercises were performed using variable resistance machines, free weights, and ankle weights.

• The study sample was comprised of three male and seven female patients; five patients completed the intervention.
• The study had an upper-age limit of 90 years old.
• Patients had lower-limb lymphedema, with at least 6% discrepancy in the affected limb and did not have an infection.

The study has clinical applicability for late effects and survivorship.

The study used a pre-post design with no control.

• A Perometer was used to calculate limb volume.
• Multiple leg circumference measurements were taken.
• Patients completed a lymphedema survey.
• A visual analog scale assessed associated pain.
• Patients completed the 36-Item Short Form Health Survey (SF-36).
• Patients took six-minute walks.
   

All but one person attended at least 81% of supervised sessions. Five patients did not complete the study because of cellulitis that occurred early in the study, progression of cancer, and inconvenience. There were no significant differences in lower-limb volume. Strength increased and the six-minute walk increased.

The study was too small to draw any conclusions, and the number of drop outs for various reasons makes the feasibility of this approach for patients with lower-limb lymphedema questionable.

The sample size was small, with less than 30 participants.

 The study is one of few that begins to address lower-limb lymphedema. Further study on the safety and potential benefits of exercise and weight training for this condition are needed.

The intervention involved a 95-page teaching booklet, What to Expect From Your Oral Cancer Surgery: A Guide for Patients and Families. The booklet included information about oral cancer, treatments, and effective coping strategies. Contents were divided into preparing for surgery, postoperative care, and returning home.

In the intervention group, the booklet was given to patients pre- and postoperatively by a nurse experienced in caring for patients with head and neck cancers. The preop session was 60–90 minutes of individual teaching before admission to the hospital for surgery. The predischarge session was 60–90 minutes of individual teaching several days prior to expected discharge from the hospital.

In the control group, patients received standard level of care, which included a preop meeting with the surgeon for consent to treatment as well as a brief description of the illness and treatment. Also included in the preadmission information was a tour of the ward and a team visit from the physician, dietitian, social worker, speech therapist, and enterostomal nurse. No information about coping or emotional difficulties was provided routinely. Measurements were taken at baseline, predischarge, and three months follow-up.

• The sample was comprised of 19 patients newly diagnosed with head and neck cancer who were scheduled for their first surgery.
• The intervention group had 10 patients, and the control (standard care) group had 9 patients.

• Hospital setting
• Toronto, Ontario, Canada

A randomized controlled trial design was used.

• Demographic/disease history tool
• Observer-Rated Disfigurement Scale
• Short Michigan Alcoholism Screening Test (SMAST-13): Used to measure history of alcoholism
• Medical Outcomes Study (MOS) Social Support Survey
• Recent stressful life events checklist for chronically ill populations
• Knowledge questionnaire to measure oral cancer–related knowledge
• Stanford Inventory for Cancer Patient Adjustment (SICPA): Used to measure self-efficacy
• State-Trait Anxiety Inventory (STAI)
• Center for Epidemiologic Studies–Depression scale
• Affect Balance Scale: Used to measure quality of life (QOL)
• Body Image Scale
• Atkinson Life Happiness Rating Scale: Used to measure QOL in medically ill populations
• Illness Intrusiveness Ratings Scale
• EORTC QOL questionnaire: Five-item patient satisfaction survey
• Analysis of stats: Simple ANOVA (group x time interaction)

The authors reported significant improvement in anxiety scores within the intervention group from time 1 to time 3 (t = 2.88, df = 9, p = 0.018).

• The study had a small sample size.
• The intervention was a booklet created by a psychiatrist, head and neck surgeon, health psychologist, head and neck dietitian, head and neck speech-language pathologist, nurse educator, and medical illustrator, with patient focus groups as reviewers. This would be costly to replicate.
• An RN spent 60–90 minutes with each patient/family to teach, both preop and predischarge.

To assess the effect of oral cryotherapy on development of oral mucositis associated with infusion of fluorouracil (5-FU) with leucovorin

Patients were randomized to cryotherapy or usual care. Prior to randomization, patients completed a study questionnaire, and 60 patients, who had similar characteristics, were selected for randomization. Ice chips were given to patients in the treatment group 5 minutes before and throughout treatment for a total of 30 minutes of continuous use. Mucositis assessment was done on days 7,14, and 21 after chemotherapy.

• The study reported on 60 patients. Ages were not stated.
• The sample was 50% male and 50% female.
• More than 70% in each group did not brush their teeth, and none had gone to a dentist. All were receiving bolus 5-FU treatment. Patients with oral problems at baseline or head and neck cancer were excluded. Gastric and colon cancers were most common in the sample.
• Just more than half (53.3%) of patients were elementary school graduates. 

This was a single-site study conducted in an outpatient setting in Turkey.

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized controlled trial (RCT).

The World Health Organization (WHO) mucositis grading scale was used to assess mucositis severity.

On days 7 and 14, more patients in the experimental group did not have mucositis (p < 0.05). On day 21, patients in the experimental group tended to have lower-grade or grade 0 mucositis, but the difference was not significant.

Findings demonstrated a short-term benefit of cryotherapy in patients receiving 5-FU.

• The sample size was small, with fewer than 100 patients.
• A risk of bias exists because of the lack of blinding and no appropriate attentional control condition.
• The findings are not generalizable as no information about usual care was provided. Investigators selected the group of patients for randomization, which could have biased results. This was a group of patients who did not have any normal oral care, such as routine toothbrushing or ongoing dental prophylaxis. Findings may not be applicable to other groups. No information on oral pain, use of pain medication, or use of other interventions for oral care were included.

Findings suggest that short-term cryotherapy may be beneficial for patients receiving bolus 5-FU; however, longer-term effectiveness may not be seen.

To evaluate the probability and usefulness of ablation on pain when performed via local anesthesia

Lesions targeted included spinal, sacral, and extraspinal. A visual analog scale was used to evaluate pain from 0–10 pre- and post-procedure, after one week, at 3 months, at 6 months, and at 12 months. Only three patients had data at 12 months.

• N = 15
• AGE: Not defined
• MALES, FEMALES: Not defined
• KEY DISEASE CHARACTERISTICS: Lesions included spinal, sacral, and extraspinal locations.

• SITE: Single site
• SETTING TYPE: Not specified

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

• Retrospective study

• Visual analog scale from 0–10

The mean ablation time was 4.09 minutes, with an average of 4.2 cycles and mean ablation power of 60 W. Pre-procedure pain score was 7.2 (SD = 0.97). Post-procedure, mean visual analog scale scores were 1.64 on day 0, 1.82 on day 7, and 2.05 by the end of one month. At three months, the mean pain score was 2.13, and at six months, it was 2.36. One patient had no pain relief by one month, and follow-up was discontinued. One patient had a soft tissue abscess at the ablation site, which was drained. No other major or minor complications were found.

Microwave ablation of bone lesions may have some promise for relief of bone pain in patients with cancer.

• Small sample
• No comparison group
• No blinding

This study suggests that microwave ablation of painful bone lesions may be feasible and may substantially reduce bone pain. This was an extremely small sample. Further well-designed studies are warranted.

To determine whether a difference exists between conventional and alginate bandaging in regard to lower-volume increase or re-filling of the lymphedema when the bandages are applied in periods with reduced decongestive therapy.

The study included an A group and a B group who received 22 days of treatment with manual lymphatic drainage (MLD) including three inpatient weekends. On inpatient weekends low-stretch compression dressing and alginate semi-rigid bandaging were compared. Patients using low-stretch compression dressings (Group A) had bandages applied Friday evening after MLD and then again on Saturday and Sunday after receiving intermittent pneumatic compression (IPC); patients were instructed to not remove bandaging during sleep. Group B used alginate semi-rigid bandages and also were bandaged after MLD on Friday. Patients were instructed to not remove this bandage for the entire weekend. IPC took place in this group with the bandage remaining in place. Volumes were measured prior to bandaging on Friday and then again on Monday prior to MLD.

• The sample (N = 61) was comprised of female patients with breast cancer.
• Mean age of patients was 57.4 years ± 8.926, with a range of 28–81.
• Five patients had a modified mastectomy and 56 had a lumpectomy.
• Thirty-five patients underwent radiation therapy with three receiving adjuvant therapy.
• Six months prior to admission in the study, 41 patients underwent non-standardized treatment with MLD and a compression garment.

• Single site
• Inpatient setting
• Austria

The study used a randomized controlled trial design.

• Volume measurement by Kuhnke, starting at ulnar styloid process to proximal circumference, was measured every 4 cm.
• Sonograph of skin thickness at middle-ventral upper arm, middle-ventral forearm, and the middle-back of the hand.

There was a statistical difference between the two groups in terms of volume depletion on days 1–5 (p = 0.010). Days 5–8 had a significantly smaller difference (p = 0.001) and days 8-12 was insignificant. Days 12–15 had a significant statistical difference (p=0.001), days 15–19 not significant, and days 19–22 significant (p = 0.003). All significance was in favor of Group B, although the overall statistics were not significant. In terms of tolerance, Group B using the alginate semi-rigid bandage had a statistically significant difference in comfort on the second (p = 0.0004) and third (p = 0.024) weekends.

Although there was no significant difference in volume depletion for women from Group A to Group B, there was a statistically significant difference in the overall comfort of patients in Group B with the semi-rigid bandaging, which can directly impact the women’s quality of life during treatment for lymphedema.

The sample size was small (N < 100).

Some positive changes in women with lympedema rely solely on patient education and compliance with exercise. Patient education and physical therapy must be included in after surgery.

To evaluate the effects of professional oral health care (POHC) given by dentists and dental hygienists on the development of oral mucositis and FN after allogeneic BMT.

1.    Pre-BMT, two dentists examined patient’s oral health, including x-rays, baseline hygiene, and clinical exam of hard and soft palate, looking for risk factors for oral infection.  
2.    All dental problems were treated up until HSCT.
3.    Dental hygienist gave mechanical cleaning of the mouth and instructed patients on how to properly clean the mouth and teeth.
4.    During HSCT period, all patients had to be able to perform proper oral hygiene themselves, which included brushing their teeth after every meal and before going to bed and oral rinsing with normal saline solution every three hours during the day.
5.    When xerostomia developed, a mouth-wetting agent containing baking soda was applied locally several times a day.
6.    Dentists and hygienists performed weekly oral exams and POHC on all patients and monitored compliance.
7.    When OM developed, extra-soft toothbrushes were used, and patients gargled with a saline rinse containing lidocaine. Opioids were used for severe OM pain.  
 

The sample was comprised of 140 patients. The median age for non-POHC was 43 (with a range of 15-66 years), n = 62. The median age for POHC was 47 (with a range of 18-77 years), n = 78.   

Males (%): 54; Females (%): 46

Key Disease Characteristics: Adult patients with ALL, AML, MDS, CML, malignant lymphoma, adult T-cell leukemia/lymphoma, MM, and other (6.7%)

Other Key Sample Characteristics:

1.    BMT was done by conventional or reduced-intensity stem cell transplantation.
2.    Conditioning regimens included Fludarbine/Busulfan, Fludarabine/Melphalan, Cytoxan/VP-16/total body radiation, Cytoxan/total body radiation, and others (8.6%).
3.    Cyclosporine A or tacrolimus and short-course methotrexate were given for GVHD prophylaxis.
4.    Median age, administration of Cytoxan/VP16/TBI and GVHD prophylaxis were significantly different between groups.
5.    The number of reduced-intensity stem cell transplant (RIST) was higher in the POHC group.
 

Site: Inpatient

Location: Hokkaido University Hospital, Sapporo, Japan

Phase of Care: Active treatment

Retrospective study from February 2002 until December 2009.  Data collected from clinical records.

1.    OM was graded using the WHO scale.
2.    Daily exams by nurses and physicians per instructions of the dentist in charge and at least weekly confirmation of assessments by dentists. (It is not stated if this is only in the POHC arm, but it is likely only in the POHC group.)
3.    FN was defined as a single axillary temperature of >37.5°C with a peripheral neutrophil count of <0.5 X 10⁹/L.    
 

1.    The incidence of OM was significantly lower in the POHC group (66.7% versus 93.5%).
2.    The incidence of FN and maximal level of CRP were both significantly lower in the POHC group (P < 0.035).
3.    The conditioning regimen and POHC were significantly associated with the incidence of OM in the univariate analysis.
4.    Only POHC remained significant in the multivariate analysis.
 

The incidence of OM in patients with POHC was significantly lower than in those without POHC.

Retrospective study

Higher number of RIST patients in the POHC group, which may account for the lower number o f cases of OM seen.

Long time from the non-POHC group and POHC make comparison to historical control less accurate. Additional intervening variables could be responsible for changes seen.

1.    This retrospective study helps to support the need for diligent oral hygiene prior to and during OM in high-risk patients.
2.    The intervention in this study is not expensive and does not introduce additional medications to patients, which put the patient at risk for additional side effects.
3.    This study reinforces the use of saline rinses.
4.    FN was lower in the study group, and interventions that can help decrease the incidence of this significant and sometimes deadly side effect of chemotherapy are worth considering (perhaps the risk of infection via the oral cavity was reduced through the use of meticulous mouth care).
5.    This intervention would require education to the patient and the caregivers prior to treatment and monitored during treatment, which oncology nurses are well positioned to do.
6.    This study was done inpatient, and it would be nice to see an outpatient prospective study done to see if the results are the same.
 

To determine the effects of massage on sleep quality in patients with breast cancer

A random sample of women in a chemotherapy clinic was obtained, and individuals randomly were assigned to control and experimental groups. Those in the experimental group received effleurage style massage therapy by a certified practitioner for 20 minutes three times a week for four weeks in the clinic. Patients in the control group received usual care. Study measures were obtained at baseline and at four weeks.

• N = 57
• MEAN AGE = 43.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were an average of 3.5 months after surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: About 13% in both groups were receiving hypnotics.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Iran

• PHASE OF CARE: Active antitumor treatment

• Single-blind RCT

• Pittsburgh Sleep Quality Index

In the experimental group, sleep latency, use of hypnotics, and sleep time improved (p < .001) from baseline. In the control group, sleep adequacy and use of hypnotics also improved (p < .05). No differences were seen in quality of life between groups.

Massage therapy may improve some aspects of sleep in women with breast cancer during active treatment.

• Small sample (less than 100)
• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The measurement used for quality of life is not described. The control group had overall lower sleep quality at baseline and more use of hypnotics. Because massage was done in the chemo clinic, whether contamination could have occurred with the control group in the same clinic is not clear. Reporting is unclear. Verbal discussion of results does not match tabular information.

Although this study does not provide strong support for the effectiveness of massage to improve sleep quality among women during therapy, massage is a low-risk intervention and these findings suggest that it might be helpful. For patients with sleep disturbance, massage may be an alternative that is helpful and preferred by some patients.

To investigate the effects of inoculation training on stress, anxiety, and depression

Forty patients were randomly selected and randomly assigned to study and control groups. Study group patients had weekly group education sessions for eight weeks. Sessions were aimed at understanding stress, relaxation, education, concepts of cognition, feelings and behaviors, role of negative self-talk, concentration and distraction techniques, and problem solving skills. Data were obtained before and after the intervention period.

• N = 40  
• AGE RANGE: 28-65 years
• MALES: 31.73%,FEMALES: 68.27%
• KEY DISEASE CHARACTERISTICS: Patients had non-hematologic cancers and were in the third course of chemotherapy. None were receiving radiation therapy.

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

• PHASE OF CARE: Active antitumor treatment

• Randomized, controlled trial

• Depression Anxiety and Stress Scale (DASS)

Anxiety and depression declined after the intervention, but did not decline in the control group. After eight weeks, anxiety was significantly lower in the intervention group (p = 0.00) and depression was significantly lower than controls (p = 0.04). Stress increased in the control group, but declined in the intervention group (p = 0.01).

The psychoeducational intervention tested here was associated with significantly less anxiety and depression compared to patients who did not receive this intervention.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Other limitations/explanation: No information is provided about the types of cancer, stage of disease, type of chemotherapy provided, other associated symptoms, or use of medication that may affect anxiety or depression–all of which could be expected to influence outcomes. The specific timing of postintervention measurement is not stated.

Findings suggest that the type of psychoeducational intervention provided here was helpful to manage anxiety and depression. Study design limitations affect the strength of evidence from this particular study; however, findings are in general concert with the body of evidence regarding effectiveness of psychoeducational interventions. Various psychoeducational interventions have been shown to be effective for anxiety and depression. These interventions can be incorporated into usual nursing practice.

To determine the effect of an oral mucositis prevention protocol on nutritional status and quality of life in patients receiving radiation therapy for head and neck cancers

The intervention group received an oral care protocol that included tooth brushing, features of the tooth brush, and a sodium bicarbonate mouth rinse. It also included an oral evaluation, precautions for oral mucositis, and a nutrition protocol. The nutrition protocol consisted of recommendations for wounds, irritation, intensive secretion, xerostomia, smell or taste changes, nausea, vomiting, and nutritional principles after radiation therapy (RT). The protocols were used for preventing oral mucositis and malnutrition, and interventions were used according to the grading of mucositis. Assessments were done weekly for seven weeks.

• N = 50  
• AGE = less than 39 to greater than 60
• MALES: 86%, FEMALES: 14%
• KEY DISEASE CHARACTERISTICS: Nasopharyngeal, laryngeal, salivary gland, gingiva, hypo pharyngeal, and tongue
• OTHER KEY SAMPLE CHARACTERISTICS: Education status from illiterate to high school or higher

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Turkey

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

Randomized, controlled, experimental study

• Face to face interviews were done using an oral assessment guide, oral toxicity scale from the World Health Organization (WHO), a Visual Analog Scale (VAS), the Subjective Global Assessment (SGA) index, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).
• A data analysis was conducted using SPSS v15.0 and SigmaStat v3.5.

Oral mucositis severity was lower in the group receiving the oral care protocol compared to the control group. As the post-treatment period progressed, the prevalence of malnutrition in the intervention group was lower than the control group, and the intervention group experienced significantly less pain related to oral mucositis. A similar deterioration in quality of life was noted in each group.

Oral mucositis severity was lower in the two groups receiving the oral care protocol compared to the control group. This study demonstrated that oral mucositis rate may be reduced with an oral care protocol.

• Small sample (< 100)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: This study reported a number of patients who experienced occasional breakdowns in RT treatment devices with delays that could have affected results. It was not clear what care patients in the control group received when they developed mucositis.

Nurses working in RT units should explain oral care protocols to patients before treatment and assess patients' mouths every week using evidence-based assessment criteria. Healthcare professionals should evaluate the nutritional status of individuals receiving RT before, during, and after treatment, and patients should be offered education and training. Nurses should use evidence-based protocols for patient care. This study added to the body of evidence pointing to the importance and effectiveness of standardized oral care for the reduction of mucositis severity.