To evaluate the effects of reflexology in comparison with two comparator interventions (reflexology and massage) on cancer-related quality of life, relaxation, mood, and adjustment in women with newly diagnosed early-stage breast cancer

Women were randomized to one of three interventions:

• Intervention 1: reflexology plus self-initiated support (SIS)
• Intervention 2: scalp massage plus SIS (comparator intervention – identical amount of physical and social contact)
• Intervention 3: SIS (comparator intervention – treatment as usual; this was the control group).

Patients receiving reflexology or massage received eight one-hour sessions at weekly intervals for eight weeks, beginning seven weeks after surgery. Patients were assessed by a clinical and research specialist nurse (blinded to treatment allocation) before randomization (week 6 post-surgery), 18 weeks after surgery (primary end point 1), and 24 weeks after surgery (secondary end point). Seventy-five percent of women received all eight sessions of reflexology, and 75.4% received all eight sessions of massage.

• The study reported on a sample of 183 patients: 60 in the reflexology group, 61 in the massage group, and 62 in the SIS group.
• Mean patient age was 59.37 ± 10.46 (range = 32–81) in the reflexology group, 57.70 ± 10.12 (range = 36–76) in the massage group, and 59.36 ± 10.23 (range = 36–77) in the control group.
• All patients were diagnosed with early-stage breast cancer; the sample was 100% female.
• Patients were randomized six weeks after breast surgery (not controlled for treatment type). It appears that most patients were receiving chemotherapy, radiation therapy, or both, but the authors were unable to determine exactly from the sample description.

• Multisite
• Outpatient setting
• United Kingdom

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• Functional Assessment of Cancer Therapy (FACT-B)
• Trial Outcome Index (TOI)
• Mood Rating Scale (MRS)
• Hospital Anxiety and Depression Scale (HADS)
• Complementary Therapies Questionnaire (CMQ)
• Structured Clinical Interview for DSM-IV-TR (SCID)

There were no significant differences between groups on any measure or demographic variable at baseline. At the primary end point (week 18), TOI scores for the three groups differed significantly: massage patients had significantly higher scores on the TOI (indicating a better quality of life) than those receiving SIS. The difference existed only between massage and SIS. There were no differences among groups in self-reported quality of life as measured by FACT. MRS scores at the primary end point showed that massage and reflexology patients were significantly more relaxed than those randomized to SIS, and total MRS scores for reflexology and massage patients were significantly higher than for SIS patients. At this end point, massage patients were significantly more easygoing than either reflexology or SIS patients. Scores on HADS anxiety and depression did not differ significantly between the three groups. At the second end point (week 24), reflexology patients were significantly more relaxed than SIS patients measured by TOL and MRS. Scores on HADS anxiety and depression did not differ significantly between the three groups.

The authors concluded this was a well-controlled and rigorous study with an adequate sample size. Overall, however, there was low psychiatric morbidity in this sample, and despite the high compliance with the interventions (reflexology and massage), there were really no significant differences in the two end points in the depression scores.

• The study did not include an appropriate control group.
• The study design lacked an attentional control.

Findings do not support effectiveness of reflexology for reduction of depression or anxiety.

To determine the magnitude and duration of pain relief in patients receiving IV lidocaine and placebo infusions, to explore the efficacy and potential uses of IV lidocaine for pain relief in opioid-refractory cancer pain, and to evaluate the safety profile, specifically acute side effects

Patients received infusions of lidocaine and placebo in random order with 14 days between the two infusions. Patients were to record their average daily pain score for 14 days after each infusion.

• The study consisted of 50 patients.
• The mean age of patients was 67 years with a range of 34–91 years. 
• The sample consisted of 22 females and 28 males.
• All patients were at least 18 years of age suffering from opioid-refractory cancer pain. Patients had to consent to no change in analgesic therapy from 48 hours before and 24 hours after completion of the scheduled infusion.

This was a single-site study conducted in India.

This was a randomized, double-blind, placebo-controlled, crossover study.

Pain was measured using a numeric analog scale (NAS) ranging from 0–10, with 0 being no pain and 10 being worst imaginable pain.

• Onset of maximum analgesic effect after initiating lidocaine infusion was 40 minutes (SD = 16.28) compared to 74.8 minutes (SD = 33.39) for saline (placebo).
• Duration of pain relief after lidocaine was 9.3 days (SD = 2.5) compared to 3.8 days (SD = 1.8) with saline.
• The mean pain score during the 14-day observation period was 1.4 for lidocaine and 5.2 for placebo.
• Frequency of rescue medications after lidocaine infusion was 1.45 per day with lidocaine compared to 1.76 per day with placebo infusion.
• During the peri-infusion period, up to two hours post, a decrease in heart rate was observed.
• After lidocaine infusion, 26 patients experienced at least one side effect; 18 patients experienced at least one side effect after placebo.
• Side effects developed earlier in patients receiving the lidocaine infusions.
• Side effects included tinnitus, perioral numbness, sedation, lightheadedness, and headache. All were self-limited and did not require intervention. One patient withdrew from the study because of severe tinnitus.

The average duration of pain relief in this study after a single infusion of lidocaine was 9.34 days.

• The investigators did not account for the progressive nature of the disease and its possible effect on pain.
• The study used a lower dose of lidocaine at a slower rate of infusion compared to the available literature.
• A possible carryover effect (despite a 14-day interval between dosing) may have occurred.
• The study did not evaluate the safety profile of IV lidocaine.
• Findings did not differentiate between the effects of the intervention on nociceptive and neuropathic pain and analgesia.

Further studies are indicated to establish guidelines and investigate the safety profile for the use of IV lidocaine.

To evaluate the effect of oral cooling using ice-rolls on chemotherapy-induced mucositis in patients administered bolus 5-FUFA

Randomized, control trial of 53 patients with gastroinstenal tract cancer receiving 5-fluorouracil (5-FU) in an outpatient clinic either daily for three, four, or five days (n = 22) or weekly (n = 31). The intervention group (n = 27) was asked to do oral cooling using ice-rolls in and out of oral cavity for the following schedule (10 minutes before administration, 5 minutes during administration, and 15 minutes after the administration of 5-FU). Patients used oral cooling for a total of 30 minutes (SD = 5 minutes). Assessment of oral cavity was conducted every week for three weeks.

• N = 53 patients
• AGE = 18–73 years
• MALES: 53.7%, FEMALES: 52.3%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastrointestinal tract cancer

• SITE:Single site
• SETTING TYPE:Outpatient
• LOCATION: New Delhi

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• World Health Organization (WHO) Oral Toxicity Scale 
• Patient-judged mucositis grading

A significanct decrease in oral mucositis incidence was noted in the experimental group in week 1 (p = 0.001), week 2 (p = 0.014), and week 3 (p = 0.05) compared to the control group. Descriptive statistics showed only mild oral mucositis in the experimental group, whereas moderate and severe oral mucositis was reported in the control group.

Oral cooling was effective in reducing oral mucositis in patients receiving 5-FU.

• Small sample (< 100)
• Findings not generalizable
• Only one type of medication—5-FU—included

Oral cooling was 100% accepted as an intervention to reduce the incidence of oral mucositis induced by chemotherapy. Nurses need education on proper assessment tools for oral mucositis. Educational materials should also be given to patients and their families to enhance the proactivity of preventing mucositis induced by chemotherapy.

To determine the effectiveness of Lactobacillus brevis CD2 lozenges on the incidence and severity of mucositis and tolerance to chemotherapy and radiotherapy

Patients with head and neck squamous cell carcinoma (HNSCC), stages II–IVA, who were receiving chemotherapy and radiation over a seven-week period, received daily treatment with lozenges containing either L. brevis DC2 or placebo. They were required to complete at least 30 out of the planned 35 fractions of radiation treatments and at least 6 of the cisplatin chemotherapy doses. L. brevis CD2 dosing was six lozenges daily, one lozenge every 2–3 hours, dissolved first in the mouth, then swallowed.  Patients were to avoid hot beverages for at least 30 minutes before and after each treatment, to avoid affecting the efficacy of the lozenges. Placebo and active treatments were started the first day of chemotherapy and radiation therapy and continued for one week after the final treatment.

• The sample consisted of 188 patients with a mean age of 52 years old.
• The sample was 93% male and 7% female.
• Patients had been diagnosed with stage II–IVA (resectable) HNSCC.
• Patients had normal bone marrow and normal renal and hepatic function.

The study was conducted at a the Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, in New Delhi, India.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for head and neck cancer and the male population.

This was a randomized, double-blind, placebo controlled trial.

• Observation of oral mucosa using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0 mucositis grading assessment was conducted each week by the same observer.       
• Observation of the oral cavity was conducted using photographs at each visit.
• Saliva samples were tested at the start and completion of treatment to determine levels of proinflammatory cytokines, antibodies, and metalloproteinases.
• The Functional Assessment of Cancer Therapy (FACT) Head and Neck Questionnaire Version 4 was used to assess quality of life.
   

• The overall incidence of oral mucositis was significantly decreased in the L. brevis group versus the placebo group (p < 0.001). This is based on combined findings of those remaining free of mucositis (28% in the L. brevis group versus 7% in the placebo), grades I and II mucositis (similar in both groups), and grades III and IV (52% for L. brevis arm and 77% for the placebo).
• A greater percentage of patients in the L. brevis arm completed chemotherapy and radiation treatment (92%) versus the placebo arm (70%).
• Other important results obtained included less use of analgesics to control mucositis-associated pain (30% in the L. brevis arm versus 45% in placebo).
• No significant differences in survival, quality of life, or median time to onset of mucositis was found.

Probiotic L. brevis CD2 lozenges can reduce the incidence and severity of oral mucositis in the studied patient population, allowing the patients to complete the intended course of anticancer treatment. 

The study is limited by the lack of the ability to generalize the results to other groups such as women, teenagers, or those undergoing chemotherapy alone.

• The study is effective in the specific population observed. However, the ability to apply this information to other populations, such as women, children, or other types of cancers that affect the head and neck less significantly, is limited.
• To be able to recommend this intervention, it would also help to know the expected cost of and availability or access to the lozenges.
• No adverse events related directly to the intervention were found, so use of the L. brevis CD2 lozenges in the population studied could be a very effective and important option for oncology nurses to educate the healthcare team and patients.
• The nursing implications are that a thorough understanding of the physiological consequences (lack of nutrition, pain) of uncontrolled mucositis can interrupt the treatment plan. Mucositis is painful and may result in dose reductions, treatment delays, or treatment discontinuation, so it is important to be current on the most reliable interventions.

The study evaluated the effects of high dose isoflavones, equivalent to that consumed by Asian populations, on the consequences of androgen deprivation therapy (ADT) for prostate cancer, such as sexual dysfunction, poor QOL, vasomotor symptoms, and altered cognition.

The intervention contained 20 gm Revival® (Physicians Laboratories) soy protein consisting of 160 mg total isoflavones as powder to be mixed with beverages. Placebo contained 20 gm whole milk protein and similar nutrients as the intervention except for isoflavones. Active and placebo powders appeared and tasted similar. Supplements were ingested once daily for 12 weeks, and dispensed at the baseline and 6-week visits. Data were gathered at study baseline, and weeks 6 and 12. Men tolerated the compound well with only one withdrawing from study because he disliked its taste. Overall compliance was high at approximately 80%. Compliance was based on the number of sachets returned by each patient at treatment weeks 6 and 12. 

This was a 12-week pilot trial of high-dose isoflavones ingested by 39 men with prostate cancer undergoing ADT. Participants were randomly assigned to receive 20 gm soy protein containing 160 mg total isoflavones (17) versus taste-matched placebo (20 gm whole milk protein).  After enrollment, men were instructed to refrain from ingesting any kind of soy product during the 12-week study period. Thirty-three (33) completed the study.

• Inclusion criteria: Men 21 years old or older undergoing medical or surgical ADT for at least three months.
• Exclusion criteria: Hepatic, renal, thyroid or neurologic disease, active psychiatric disorder, current chemotherapy or glucocorticoids, appetite or weight promoting agents, substance abuse, triglycerides greater than 500 mg/dl, or allergy to soy protein or cow milk.

Men already on soy supplements were washed out for at least three months before entry.

Study was a randomized, double-blind, placebo-controlled trial.

Men were not well matched for hot flashes, with the isoflavones group reporting higher scores (increased distress) than men on placebo at baseline and at study end. However, within-group analysis showed no significant changes in the vasomotor distress score in either group. Using the Kupperman scale, men on isoflavones did not show any significant improvement in hot flashes compared to those on placebo. At 12 weeks, there were no significant differences between the two groups in any outcome measure. No safety issues were found during the study.

This pilot study of high-dose isoflavones in androgen deprived men showed no significant improvement in cognition, vasomotor symptoms, or any other aspect of QOL measures compared to placebo.

This pilot study had a small sample size and short treatment duration. Future studies should use variable doses of isoflavones for a longer period before ruling out beneficial isoflavone effects in this population.

STUDY PURPOSE: To determine the efficacy of yoga as a treatment option in cancer

TYPE OF STUDY: Systematic review

DATABASES USED: CINAHL, MEDLINE, and Alt Healthwatch

KEYWORDS: Yoga and cancer and intervention or program

INCLUSION CRITERIA: Quantitative design; measured anxiety, depression, sleep disturbance, pain, quality of life, and/or stress as an outcome; published since 2010; English language; included any form of yoga as part of or the entire treatment of cancer

EXCLUSION CRITERIA: Not quantitative design

TOTAL REFERENCES RETRIEVED: N = 135

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No specific method of evaluating study quality is reported.

• FINAL NUMBER STUDIES INCLUDED: N = 13
• SAMPLE RANGE ACROSS STUDIES: 536 total
• TOTAL PATIENTS INCLUDED IN REVIEW: Range = 4-240
• KEY SAMPLE CHARACTERISTICS: Six studies involved only patients with breast cancer; two involved parents of children or adolescents with cancer.

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Pediatrics

Of four studies examining effect on anxiety, two showed no effect and two showed a significant positive effect. One of these was a positive effect on parents. Two studies showed a positive effect for fatigue, and one showed no effect for fatigue. There were no effects seen for depression. One study showed a positive effect for sleep, and one showed no effect for sleep. One study of 18 breast cancer survivors showed a postitive effect for fatigue immediately after the intervention. Six of the studies used a randomized controlled trial (RCT) design. Duration and dosing of the yoga intervention varied substantially across studies. All of the studies used an instructor for the duration of the intervention. Methods of measurement used varied.

Insufficient evidence exists to draw firm conclusions about yoga’s role and effect in cancer treatment.

There were few studies, and most had very small sample sizes. No information regarding the quality of the studies was included, other than general design, as this included both RCTs and quasiexperimental studies.

There is limited evidence regarding the effects of yoga as a complementary approach in cancer treatment.

The intervention consisted of six weekly, two-hour sessions and a one-hour silent treatment session. Participants were trained in meditative practices (Kabat-Zinn), sitting meditation, body scan, Hatha yoga, and “Loving Kindness” meditation.

Participants were given didactic material on physical and psychological effects of stress and tools to cope with stress. The control group chose a stress management technique to engage in each week and used a workbook and diary.

The outcome was sleep.

• The sample was comprised of 63 women with a history of stage II breast cancer (free-choice control group, n = 32; mindfulness-based stress reduction [MBSR] group, n = 31). 
• Mean age was 57 years (range 18–80).
• The women were working, retired, or on disability.

• Participants’ homes
• Western United States

Participants were undergoing the long-term follow-up phase of care.

The study was a randomized, controlled trial.

Sleep diary and a daily diary to record the activities they engaged in for stress management

Hypotheses:

• Sleep function is associated with psychological distress:  confirmed
• Sleep efficiency would be improved after controlling for baseline distress:  not confirmed
• Sleep efficiency and sleep quality would improve with MBSR:  partially confirmed

• The study lacked compliance with the practice of mindfulness techniques; the control group was given too much leeway in their choice of activities to reduce stress.
• Patients self-reported in sleep diaries.
• Personnel trained in Kabat-Zinn and Hatha yoga are needed.

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Elder care

The results of this meta-analysis demonstrated that the use of IPC pumps could alleviate lymphedema, but no significant difference between the routine management of lymphedema with or without pneumatic pump existed.

Current trials fail to show the effectiveness of the addition of IPC pumps to the routine management of breast cancer-related lymphedema.

• There were very few studies included in this review.
• The quality of the trials included in the review was relatively low, and its conclusions need to be regarded with caution.

To evaluate the role of a multi-faceted infection control policy in decreasing the transmission of vancomycin-resistant enterococci (VRE).

A surveillance program was initiated. The use of empirical vancomycin was limited in patients with febrile neutropenia to four specific situations.

Infection control staff monitored isolation practices and educated staff and visitors.

• Tertiary hospital treating patients with cancer
• Cancer center with 417 beds

This was a prospective cohort study.

The total incidence of VRE infections declined from 0.437 in 1,000 patient days to 0.229 in 1,000 patient days.

• No conceptual model was described.
• Several measures were initiated at the same time.
• Limited to one institution
• Initiated after an outbreak
• Multiple strategies were used at once; therefore, determining which was most the effective in preventing transmission was difficult.

STUDY PURPOSE: To examine the literature about early detection and the management of breast cancer-related lymphedema (BCRL)

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 13
• TOTAL PATIENTS INCLUDED IN REVIEW = Not clearly described (only nine studies were listed in Table 1; the information from the other four studies is missing)
• SAMPLE RANGE ACROSS STUDIES: 37–1,713 (based on Table 1)
• KEY SAMPLE CHARACTERISTICS: Patients with breast cancer at risk for or with lymphedema

PHASE OF CARE: Multiple phases of care

Early intervention (physiotherapy, manual lymphatic drainage [MLD]) demonstrates a benefit of reducing the rate of BCRL. New diagnostic modalities (e.g., perometry, bioimpedance spectroscopy) may increase sensitivity for early detection of BCRL.

Developing surveillance programs that target early identification and timely interventions for BCRL management is important.

• Limited search
• No quality evaluation
• Low sample sizes
• Thirteen articles were identified by the authors as meeting the eligibility criteria and the scope of the review; however, only nine articles/studies were clearly evaluated and presented in the results section as well as in Table 1.

The review supports the beneficial impact of early detection and timely interventions of BCRL. This will inform nurses of using evidence-based strategies to make early identification and management of lymphedema in individuals with breast cancer. The quality of the review, however, is not adequate.