To evaluate the therapeutic effects of a low level He-Ne laser on chemoradiation (CRT) -induced oral mucositis (OM), associated severe pain, and use of total parenteral nutrition (TPN) in patients with oral cancer

Block randomization was done using a computerized program taking primary oral cancer stage as a matching variable of 121 primary patients with oral cancer scheduled to undergo CRT (RT dosage = 66 Gray/33 fractions for five days per week and chemotherapy was three weeks cisplatin). Patients were randomized to either laser (n = 60) or placebo (n = 61). Both groups received standard oral care and hygiene. Patients and outcomes assessor were kept blinded for the laser intervention. OM, its associated pain, and TPN were assessed every week by a blinded assessor. Opioid analgesic use, weight loss, and any CRT breaks were recorded.   

Laser treatments used He-Ne 632.8 nm, power output of 24 mW, beam spot diameter of 0.6 mm, noncontact method (Technomed Electronics, Advanced Laser Therapy 1000, Chennai, India). This was applied to the anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth and palate), excluding cancer site daily just before radiation session for 6.5 weeks.

The placebo group received sham therapy (the probe was kept off, and there was only a beep sound) just before radiation for 6.5 weeks. 

• The study reported on 121 patients with cancer of the oral cavity.
• The mean age of patients in the laser group was 51.71 years, and the mean age of patients in the placebo group was 52.60 years.
• The sample was 91% male and 9% female.

This was a single-site study in a nonspecified setting in India.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for end of life and palliative care.

This was a prospective double blinded, randomized controlled trial.

• An experienced radiology oncologist who was blinded for the intervention group performed the assessment of the oral mucositis using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring system (grade 0–4).
• The need for TPN was recorded at the end of every week.
• Opioid analgesics use, weight less, CRT break during severe oral mucositis (grade > 2), and pain severity (using a visual analog scale [VAS]) of greater than 7 were recorded.

During the last weeks of CRT, incidence of mucositis greater than grade 2 was less in the laser group than in the placebo group (p < 0.0001). The mean duration of severe grades of OM was less than in the placebo group.

At the third week of CRT, no statistical difference was found between groups for incidence of OM, severe pain, TPN, and weight loss.

The laser group had less need for opioid use (p < 0.001). None of the patients in the laser group required a break in CRT, but 9% of patients in the placebo group required a break in CRT.

OM progressed at a slower rate in the laser group than in the placebo group. Pain was less severe as rated by pain scores, and TPN was significantly less in the laser group than in the placebo group.

Low level He-Ne laser was found to decrease the incidence of CRT-induced, severe OM and its associated pain; opioid analgesic use; and TPN for patients with oral cancer.

Low level helium neon laser therapy for the reduction of chemotherapy-induced OM in patients with oral cancer appears to be helpful, but the therapy is limited because of the need for the laser and an experienced laser therapist. The laser therapy in this study included standard oral care and hygiene; therefore, laser therapy does not eliminate this need.

Long-term follow-up on the effects of laser on OM is recommended to understand the carryover effects of laser in these patients. Studies explaining the exact mechanisms of action of laser also are recommended.

To examine the efficacy of low level laser therapy (LLLT) in patients with head and neck cancer receiving chemotherapy and radiation therapy (RT)

Patients were randomly assigned to receive LLLT or sham treatment. Both groups received standard oral care and oral hygiene protocol, including frequent mouth washes with sodium bicarbonate. Patients in the LLLT group were treated with helium neon laser in 15–20 minute sessions, five sessions per week, at six anatomical sites in the oral cavity. Treatment was done daily prior to RT for 45 days. Patients, outcomes assessors, and statisticians were blinded to patient group assignment. Oral mucositis was assessed and graded daily.

• The study reported on 221 patients with a mean age of 55.4 years (SD = 11.4 years).
• The sample was 85.5% male and 14.5% female.
• All patients were newly diagnosed and receiving 100 m/m² cisplatin on days 1, 22, and 43 and 66 Gy radiation in 33 fractions, five days per week.
• All had stage 3 or 4 disease.  

This was a single-site, outpatient study conducted in India.

Patients were undergoing the active antitumor treatment phase of care.

The study design was a randomized triple-blind sham-controlled randomized clinical trial.

• The European Organization for Research and Treatment of Cancer (EORTC) mucositis scoring system was used.
• The need for supplemental analgesics and parenteral nutrition was recorded.
• A visual analog scale was used to measure pain.

• Oral mucositis increased in both groups over time, but progressed more slowly in the laser group (p < 0.0001).
• At the end of treatment, incidence of grade 3–4 mucositis was about three times lower in the laser group.
• Duration of severe mucositis was less with the laser group.
• The average number of RT fractions after which severe mucositis developed was higher in the laser group. 
• Average pain scores were consistently lower in the laser group (p < 0.00001).
• The need for total parenteral nutrition was lower in the laser group (p < 0.00001). 
• Fewer patients in the laser group required any treatment delays.

Prophylactic LLLT in patients with head and neck cancer receiving concomitant radiation and chemotherapy was effective in reducing the incidence of severe oral mucositis.

Without a longer-term follow up, long-term effects of LLT are not known.

Prophylactic use of LLLT was able to prevent and treat severe oral mucositis in this group of patients. This study adds to the growing body of evidence supporting the effectiveness of LLLT in patients with head and neck cancer receiving treatment, particularly in patients receiving chemotherapy with RT. Nurses can advocate for the use of LLLT in this patient population.

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.