To evaluate the effects of low level laser therapy (LLLT) for the prevention and treatment of radiation-induced oral mucositis (OM) in older adult patients with head and neck cancer (HNC)

• N = 46  
• AGE = Older than 60 years
• MALES: 20 (90.9%) in the laser group and 19 (79.2%) in the placebo group, FEMALES: 2 (9.1%) in the laser group and 5 (20.8%) in the placebo group
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Primary HNC
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with lock jaw, any medical condition affecting healing mechanisms like diabetes, and who had prior radiation for HNC or were receiving any chemosensitizer were excluded.

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

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

• Randomized, placebo controlled trial

• Radiation Therapy Oncology Group/European Organization for Research and Treatment for Cancer (RTOG/EORTC) scoring system for OM
• Visual Analog Scale (VAS) for pain and weight loss
• Weight changes
• Data analysis was done using descriptive statistics.
• ANOVA tests of repeated measures
• Shapiro-Wilk test to test the normality of the data

LLLT seems to be an effective intervention in preventing OM in older adult patients with HNC. Larger, multisite trials are needed for validation.

• Small sample (< 100)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Patients all were said to have been kept on “standard oral care,” but that was never defined.
• Lack of inter-rater reliability in using the scales, no mention of training or consistency in using the scales between the radiation oncologists
• No mention of the calibration of the scales used to measure weight or mention of who weighed the patients

Nurses are vital in educating patients on good oral hygiene both before and during radiation treatments. Nurses see patients weekly, sometimes daily, and are essential to managing OM while patients undergo treatment, in combination with other methods such as LLLT investigated in this study. Reducing OM allows more patients to finish treatment.

To determine the effectiveness of a home-based independent exercise regimen, comprised of upper-limb resistance exercises and deep breathing exercises, in relieving lymphedema symptoms and improving quality of life

Participants received education from a qualified physiotherapist on how to perform the at-home exercise regimen for the first few sessions. Once satisfactory performance of the exercises had been completed, the patients received a handout about the exercise program and a log book to journal their progress. The exercise regimen was to be performed five days a week. Deep breathing exercises were to be performed between each set. It was recommended to only increase the weight if 2 sets of 15 repetitions became very easy to perform. The exercise regimen consisted of scapular retraction, shoulder extension, scapular protraction, scapular depression, elbow flexion, elbow extension, wrist flexion and extension, and ball squeeze. Patients were monitored weekly via telephone, and the fourth week all patients had a follow-up appointment with the investigators either in the home or at the hospital.  
 

• The sample (N = 32) was comprised of female patients with breast cancer (stages I–II).
• Mean age of the sample was 46.56 years.
• All patients had underwent a unilateral mastectomy.
• One and a half years before study participation, patients completed neoadjuvent chemotherapy and radiation (March 2006–February 2008).
   

The study took place at multiple sites in Manipal, India.

Patients were transitioning between phases of care.

The study used a pre-post design. 

• The arms were measured using two different methods, arm circumference and water displacement, to determine volumetric changes.
• Quality of life was assessed using the 36-Item Short-Form Health Survey (SF-36).

A statistically significant reduction in upper-limb circumference was found at three measurements (p < 0.001) and in affected upper-limb volume (p<0.001). The mean volume reduction was 122 ml. The metacarpophalanfeal joint circumference reduction measurement was not found to be statistically significant (p = 0.04). A statistically significant change in quality-of-life score from the SF-36 was found after completion of the exercise regimen.

The study has shown statistically significant improvements in limb volume and circumference reduction as well as improvement in QOL using this at-home exercise program.

• The sample was small (N < 100).
• The study did not have a control group or random assignment (all patients received the intervention).
• Patient adherence to the exercise regimen can affect results.

Because the findings from the study is statistically significant, it would be great for this research to be repeated with a more rigorous study design (i.e., randomized controlled trial) with a larger sample size to clarify effectiveness of the exercise regimen. If repeatedly proven that this exercise regimen is effective in reducing lymphedema, it would be a good program for nurses to teach their patients during discharge instructions because it is extremely simple and anyone can complete the exercises with common household items.

STUDY PURPOSE: To determine the effectiveness and safety of kinesiology taping (KT) compared to compression bandaging

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 6 studies, 5 in meta-analysis 
• TOTAL PATIENTS INCLUDED IN REVIEW = 203
• SAMPLE RANGE ACROSS STUDIES: 190–70
• KEY SAMPLE CHARACTERISTICS: All had breast cancer–related lymphedema.

PHASE OF CARE: Late effects and survivorship

No statistically significant difference existed between KT and compression bandaging, although the analysis showed overall results in favor of compression bandaging with or without CDT. In five of the six studies, 10%–21% dropped out because of skin-related adverse events. Skin adverse events were reported only in KT groups. The findings regarding patient discomfort or satisfaction with the intervention were mixed. Reported limb reduction volumes varied widely. Four or five studies in the meta-analysis showed greater limb reduction volume in the compression bandaging group.

KT produced lower limb reduction volume and was associated with more skin adverse effects. No difference existed in patient comfort with KT versus compression bandages.

• Mostly low quality/high risk of bias studies
• High heterogeneity
• Low sample sizes

The findings of this analysis did not provide strong support for the use of KT because no better volume reduction existed and it was associated with more skin problems. If used in clinical practice, KT should be used with caution in patients where bandaging cannot be used. No evidence exists regarding KT use other than for upper extremity lymphedema in this review.

To evaluate the efficacy of garlic compounds to reduce the risk and severity of infections among patients with hematologic malignancies

Patients were stratified according to National Comprehensive Cancer Network criteria for febrile neutropenia (FN) to receive either garlic or a placebo. Patients began the intervention after the last day of their courses of chemotherapy and continued until the resolution of neutropenia. Garlic was given in two doses of 450 mg active compound per day.

• N = 95
• MEAN AGE = 56 years (range = 20–82 years)
• MALES: 64.2%, FEMALES: 35.8%
• KEY DISEASE CHARACTERISTICS: Patients had acute myeloid leukemia, non-Hodgkin lymphoma, acute lymphoblastic leukemia, Hodgkin disease, and other types of hematologic malignancies; most patients had active disease at the time of the study and slightly less than half had previous FN in both study groups 
• OTHER KEY SAMPLE CHARACTERISTICS: Greater than 60% of patients in both groups were receiving trimethoprim or sulfamethoxazole.

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Israel

• PHASE OF CARE: Transition phase after active treatment

Placebo-controlled, double blinded, randomized trial

• Complete blood counts
• Primary outcomes were time to and onset of fever greater than 38°C   
• Number of FN episodes

The majority of patients in both groups developed neutropenia and febrile episodes at similar rates. The number of positive cultures was similar. More patients receiving garlic stopped before the end of the period of neutropenia (19.5% in the garlic group compared to 4% in the placebo group). In the very high-risk group, more patients receiving garlic developed fever. In the intermediate risk group, fewer patients receiving garlic developed fever. There were no adverse events associated with garlic use.

Garlic did not appear to provide any protective effect against the development of febrile episodes during neutropenia in these patients.

• Small sample (< 100)

Garlic extract appeared to be safe for patients with hematologic malignancies but did not show any efficacy for the prevention of fever or infection during neutropenic periods.

The comprehensive coping strategy program (CCSP) provided patients with information emphasizing the use of pain control to decrease psychological distress and physical symptoms, such as fatigue. Patients were provided with handouts that explained ways to reduce pain, the use of cognitive restructuring information on distorted thinking, and positive coping self-statements. Patients were taught how to perform a brief muscle relaxation, which included a guided imagery component. Handouts were provided that described relaxation therapy and its benefits. A handheld recorder was given to patients to guide them through the relaxation exercise. Patients were instructed to use a five-minute audiotape recording at least every day and before stressful events. Patients were instructed to record their use of audiotapes and handouts in a diary. Outcomes were assessed at baseline, two days before allogeneic bone marrow transplant (ABMT), and seven days after ABMT. 

• In total, 128 women with breast cancer scheduled for ABMT were included.
• Most patients were aged between 41 and 50 years.
• Of the patients in the CCSP group, 90% were married, which was significantly higher than the control group (57% married; p < 0.001), and 40% had practiced some earlier coping method, which was significantly higher compared to 21% of the those in the control group (p < 0.05).

National Cancer Institute (NCI)–designated comprehensive cancer center located in the eastern United States

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled, prospective clinical trial that included

• Patients scheduled for ABMT who received the CCSP
• Patients scheduled for ABMT who received standard medical care.

Visual analog scale (VAS)

Fatigue was experienced by 91% of the participants. The peak fatigue level was observed days before ABMT for both groups; the CCSP group experienced a 10.80-point increase, and the control group experienced a 20.33-point increase. The CCSP group experienced a statistically significant improvement in fatigue seven days after ABMT in comparison to the control group (p < 0.05); however, this difference disappeared after controlling for demographic variables and fatigue two days prior to ABMT. An index of nausea and fatigue was created for day seven after ABMT, and there was a statistically significant difference between the groups, with demographic variables controlled, with the control group reporting more nausea and fatigue than the intervention group (p < 0.05).

The generalizability of the results was limited to the sample, which consisted primarily of highly educated, married, Caucasian women with high incomes.

To evaluate previous findings regarding the effectiveness of lysergic acid diethylamide (LSD)-assisted psychotherapy

Participants were recruited through general information in media, flyers, cancer support groups, and hospitals. Patients were randomized to the LSD group receiving an oral dose of 200 mcg LSD or to an active placebo of 20 mcg LSD. Participants were required to taper off antidepressants and antianxiety medications and avoid alcohol and recreational drugs for 24 hours before sessions. Urine drug tests were done prior to each psychotherapy session. Two experimental sessions with LSD were completed. After each experimental session, three dug-free therapy sessions took place. A follow-up evaluation was completed two months after the second experimental session. At that time, participants in the placebo group could cross over to an identical open label treatment with LSD. The final evaluation was conducted 12 months after the last LSD-assisted session. About two-thirds of the LSD-assisted session was focused inward and one-third was brief conversation. The session ended after eight hours when acute effects subsided and was followed by a review of the day’s experience.

• N = 12  
• MALES: Not reported, FEMALES: Not reported
• KEY DISEASE CHARACTERISTICS: Not reported
• OTHER KEY SAMPLE CHARACTERISTICS: All reported a > 40 score on the State-Trait Anxiety Inventory (STAI), and half were diagnosed with generalized anxiety disorder by a structured clinical interview.  

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

• PHASE OF CARE: End-of-life care

Placebo-controlled, randomized, controlled trial

• Structured clinical interview 
• Speilberger State-Trait Anxiety Inventory (STAI)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
• Hospital Anxiety and Depression Scale (HADS)
• Patient daily diary 
• Visual Analog Scale (VAS) for pain
• State of Consciousness Questionnaire (SCQ)

The visit-by-group interaction testing for differences between groups showed a significant difference between groups (p = .033) and 65.5% power. Three of eight experimental group subjects dropped lower than the threshold of 40 on the anxiety inventory while all active placebo subjects experienced increases in anxiety. The two- and 12-month follow-up results of those who received LSD in either blinded or crossover conditions showed that benefits were sustained over time. Neither the experimental nor the placebo dose of LSD produced any severe drug-related adverse events. Adverse events reported were those commonly associated with LSD, and most resolved when the drug effects diminished. There were no events of prolonged anxiety or lasting psychotic or perceptional disorders.

This study demonstrated the safety of LSD-assisted psychotherapy sessions in a small group of patients with life-threatening diseases. There were positive trends of anxiety reduction after two LSD-assisted therapy sessions.

• Small sample (< 30)
• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs

Findings from this small pilot study suggest that LSD-assisted psychotherapy may be beneficial to patients facing the end of life to reduce anxiety. Additional research studies to confirm its safety and efficacy are needed.

To evaluate the short-term efficacy of lidocaine 5% patches for pain scars and pain caused by chest wall tumors

Patients seen in the palliative care outpatient clinic were included. They were instructed to apply up to a maximum of three patches at a time to cover the painful area for 12 hours each day. All patients had to have pain with a neuropathic component plus allodynia.

• N = 20
• MEAN AGE = 62 years
• MALES: 55%, FEMALES: 45%
• KEY DISEASE CHARACTERISTICS: 55% had lung cancer, 40% were receiving chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: All were on opioids, receiving a mean oral morphine equivalent daily dose of 125 mg per day. Seventy percent were on gabapentin or pregabalin, 45% were on corticosteroids, 5% were on antidepressants, and 45% were receiving two coanalgesics.

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

• Open-label, prospective, observational

• Numeric pain scale

Mean duration of treatment was 29.2 days (range 3–90).  Five patients discontinued in less than 10 days because of lack of efficacy. At the end of follow-up, pain scores declined by an average of two points (p < .05). Rating of breakthrough pain level declined significantly (p < .05).

Findings suggest that lidocaine patches might be helpful for some patients with pain from scarring and chest wall tumors, but the study had multiple limitations and findings lack strong support for the intervention.

• Small sample (less than 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Subject withdrawals of 10% or more
• Other limitations/explanation: Timing of follow-up measures is not stated or described, and what specific measures of pain or breakthrough pain are used is not clear (e.g., worst, average, daily, overall). Information on whether other changes in medications occurred during the same period is not provided. In the discussion, the authors state that opioid titration during the study was allowed, suggesting that ongoing medication adjustment also likely contributed to results.

Lidocaine patches might be of some help for patients with certain types of pain that are well localized and superficial. Although findings of this study were somewhat positive, the evidence is weak and this report has numerous limitations. Further well-designed, larger studies need to be done.

To evaluate the effect of a multidrug, opiate-sparing regimen for prevention of postoperative pain, nausea, and vomiting in patients after surgery for breast cancer

For 1–2 hours preoperatively, patients received a drug combination consisting of 1g oral paracetamol, 8 mg dexamethasone, 30 mg dextromethorphan, 400 mg celecoxib, and 1200 mg gabapentin. In addition, patients who were anxious received 0.125 mg triazolam on request. All patients received the same anesthesia regimen. In the postanesthesia care unit (PACU), immediately after surgery, symptoms were recorded at 15-minute intervals for 12 hours. Patients who had moderate to severe pain with mobilization received 0.1 mg/kg IV morphine and 1 g oral paracetamol every six hours and 200 mg oral celecoxib on the evening of the operation and in the morning and evening of the following day. Patients who needed pain medication after the first day received 600 mg oral ibuprofen every six hours and 1 g paracetamol every six hours. Rescue medication consisted of 15 g oral morphine.

• The sample was composed of 200 patients.
• Mean patient age was 62.7 years (SD = 12.5 years).
• All patients were female.
• All patients had breast cancer; 42% underwent a mastectomy and 58% had breast-conserving surgery.

• Single site
• Inpatient
• Denmark

Prospective trial

Four-point symptom rating scale, 0= no complaints and 3 = severe complaints

• In the first 36 hours, at rest after surgery, 30.3% of patients reported moderate to severe pain and 69.7% reported light to no pain.
• Of all patients, 22% required rescue morphine doses. The average total morphine used was 7.5 mg. The mean amount of morphine used was 2.2 mg (SD = 4.3 mg).
• Of all patients, 79% had no nausea or vomiting.
• The most common postoperative complaints were of dizziness, headache, diplopia, confusion, and memory disorder. These were similar to complaints present after administration of the preoperative regimen.

The preoperative drug combination used here appeared to be effective in preventing postoperative nausea and vomiting and may have reduced postoperative pain at rest.

• The study had a risk of bias due to no appropriate control group.
• The method of measuring pain and other symptoms is questionable.
• Whether grading was based on patient self-report or decided by hospital staff is unclear.
• The report reveals substantial differences in morphine intake based on subgroups of surgical extent; however, the sample was not large enough for authors to complete relevant subgroup analysis.
• All patients in this study received the same anesthetic regimen, so findings may not be applicable to individuals who receive different anesthesia.
• Whether pain rating was done only at rest or at rest and with mobilization is unclear.
• Only patients undergoing mastectomy were included. Findings may not apply to other surgical groups.

The specified combination of medications, administered preoperatively, appeared to reduce some postoperative symptoms in patients who had breast cancer surgery.

To evaluate the psychological effects of presurgical stress management training

Subjects were randomized to the intervention or control group by week in the hospital. The intervention consisted of four sessions of meditative exercises, relaxation, guided imagery, and counseling to promote active coping and positive attitude. Sessions were completed on days 5 and 1 before surgery and days 2 and 30 postsurgery. Patients were given a CD with the same instructions to use at home. Assessments were done on days 6 and 1 before surgery and days 2, 5, 30, and 90 postsurgery. The control group received usual care.

• N = 70
• MEAN AGE = 52 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; all stages undergoing surgery; most had lumpectomy

• SITE: Single-site
• SETTING TYPE: Multiple settings
• LOCATION: Netherlands

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)
• Profile of Mood States (POMS) scale for fatigue and depression
• Subjective sleep quality scale
• Numeric Pain Rating Scale (NRS)

Anxiety decreased after surgery in both groups. Depression decreased in the intervention group after surgery and in the control group at three months postsurgery. Depression was significantly lower in the intervention group on day 5 after surgery (d = 0.47). Fatigue increased in the control group and was significantly higher than baseline at three months postoperatively. In the intervention group, fatigue decreased and was significantly below baseline at days 2 and 5 postoperatively. Sleep problems and pain did not change in either group. Across all study timepoints, differences between groups were inconsistent. Sometimes, symptoms were higher in the intervention group, and other times, they were lower in the intervention group. An analysis was done for changes from baseline for each group rather than between groups. There were only differences in the degree of change from baseline to postoperative days 2 and 5.

The effects of the intervention were inconsistent over time and appeared to be modest and short-lasting.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Though small, the power analysis showed that the sample was sufficient to detect moderate effects. Baseline depression and fatigue levels were much higher in the intervention group, suggesting floor effects in the control patients. Six repeated measures could produce testing effects. There was no information about how often patients used the CDs at home. No information regarding other known intervention variables, including any adjuvant treatment during the study period, was provided.

The findings here were somewhat confusing and inconsistent over time; however, there were some potential short-term benefits for fatigue and depression. The combination of relaxation therapies and counseling is a low-risk intervention that may be helpful for some patients.

To evaluate the impact of quinolone prophylaxis during neutropenia on outcomes including resistance rates and hospital admissions

Researchers compared data from hospitalizations during two time periods, representing an intervention group and a control group. The intervention group included patients who received quinolone prophylaxis from 2006–2008. Prophylaxis consisted of 500 mg oral ciprofloxacin twice a day or 200 mg IV twice a day if oral medication was not tolerated. The control group included patients who received no antibiotic prophylaxis during 2005. In the event of a fever, patients in both groups began IV cefepime. If patients had a history of a cefepime-resistant gram-negative infection, they were treated with a carbapenem instead. Analysis of demographics and clinical outcomes, including occurrence of fever, duration of empirical antibiotic therapy, duration of hospitalization, and quinolone resistance, were conducted using SPSS software. Chi-square tests and Mann-Whitney tests were used for categorical and continuous variables, respectively. To evaluate patterns of resistance, data from patients outside the intervention cohort, but also hospitalized from 2006–2008, also were analyzed for resistance.

• N = 220 patients (141 in ciprofloxacin prophylaxis group, 79 in control group). Some patients were included more than once if more than 30 days passed between episodes of neutropenia. Thus, in 220 patients, 329 episodes of neutropenia occurred (219 in ciprofloxacin prophylaxis group, 110 in control group).
• AGE: Ciprofloxacin: mean age = 40 years (age range: 14–82 years); Control: mean age = 41 years (age range: 12–66 years)
• MALES: 60% in ciprofloxacin, 66% in control; FEMALES: 40% in ciprofloxacin, 34% in control
• KEY DISEASE CHARACTERISTICS: All patients were receiving intensive chemotherapy for a hematologic malignancy or undergoing hematopoietic cell transplantation (HCT). Diseases for ciprofloxacin and control groups, respectively, are primarily blood cancers, including leukemia (44%, 42%), lymphoma (26%, 21%), and multiple myeloma (26%, 28%). Other diseases represented include germ cell tumors and aplastic anemia.
• OTHER KEY SAMPLE CHARACTERISTICS: More than half of the episodes in each group included patients undergoing autologous or allogeneic HCT. Nearly two-thirds of the episodes in each group included patients with a central venous catheter.

• SITE: Single site   
• SETTING TYPE: Inpatient   
• LOCATION: Brazil

• PHASE OF CARE: Active antitumor treatment

• A retrospective, observational case-control study

For their methods, the researchers defined neutropenia as an absolute neutrophil count (ANC) less than 500/mm³. They defined bone marrow recovery as at least two consecutive days with ANC greater than 500/mm³. All blood cultures were processed using a BacT/ALERT^® system. Susceptibility tests were completed using the VITEK^® automated system. Other laboratory tests on stored bacterial cultures were used to evaluate susceptibility. These included, but were not limited to, disk diffusion, minimal inhibitory concentration, and polymerase chain reaction. Statistical tests, including Chi-square and Mann-Whitney, were completed using SPSS software.

Groups were similar in age and gender. The intervention group was statistically different from the control group in that they experienced slightly shorter periods of neutropenia (9 versus 11 days, p = 0.02), hospitalization (22 versus 24 days, p = 0.002), and antibiotic therapy (8 versus 11 days, p < 0.001); fewer febrile episodes (73 versus 93%, p < 0.001), decreased incidence of any grade mucositis (52% versus 70%, p = 0.003), and bacteremia (22% versus 33%, p = 0.04); and increased use of carbapenem (36% versus 14%, p < 0.001). The intervention group had a higher rate of quinolone-resistant bacteremia (6.77 versus 3.02 per 1,000 patients-day, p = 0.03). Quinolone-resistant enterobacteria was noted in the intervention group and patients outside the intervention cohort but hospitalized during the same time. The rate of extended spectrum beta-lactamase (ESBL)-producing enterobacteria was not significantly increased in the intervention group (0.38 in the control group versus 1.27 in the ciprofloxacin group, p = 0.26).

This study identifies benefits of quinolone prophylaxis in high-risk patients (i.e., patients with hematologic malignancies undergoing chemotherapy with an expected duration of neutropenia longer than seven days, or patients undergoing HCT), including decreased incidence of fever, bacteremia, duration of neutropenia, and length of hospitalization. Risks include an increased incidence of quinolone resistance and bacteremia because of ESBL-producing enterobacteria for the patient and hospital unit.

• Risk of bias (no random assignment)
• Other limitations/explanation: The two cohorts being compared were historical and in different time periods. The authors report no changes in hospital policy or procedures between the two time points; other differences not measured may include different staff or training. Finally, as the data were historical, not all patients included in the cohorts had bacterial samples recovered and saved for further analysis.

Quinolone prophylaxis can reduce the incidence of fever, bacteremia, duration of neutropenia, hospitalization, and duration of antibiotic therapy for select high-risk patients. Nurses should understand these benefits and the risk of quinolone resistance for individual patients in the surrounding hospital unit.