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.

RESOURCE TYPE: Expert opinion

Unable to discern any information about scope or evidence used in this article. Expert opinion.

Recommendations for the management of low-grade diarrhea include symptomatic treatment with hydration (oral) and electrolyte replacement. Prednisone 1 mg/kg can be used as necessary followed by a four-week taper. For high-grade diarrhea, patients should be treated with high-dose IV steroids (methylprednisolone 2 mg/kg) one or two times per day, which should be tapered for improvement of symptoms over four weeks, and IV hydration with electrolyte replacement. For symptoms that improve after five to seven days, or for relapse after steroid taper, infliximab 5 mg/kg once every two weeks is suggested as an alternative immunotherapy.

Limited clinical experience with managing irAEs exists because of immune checkpoint inhibitors therapy and because only patients with non-small cell lung cancer were considered.

Additional studies need to be conducted to determine the best management practice for gastrointestinal side-effect management with immune-checkpoint blocking antibodies across a variety of cancer types.

STUDY PURPOSE: To evaluate the literature with the reported use of identifying arm and breast lymphatics using the axillary reverse mapping (ARM) procedure, and the utility of using ARM with sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND), as well as the oncologic safety of its use, by reviewing ARM lymph node metastasis and the convergence of SLN and ARM nodes

TYPE OF STUDY: General review/\"semi\" systematic

• FINAL NUMBER STUDIES INCLUDED: N (studies) = 15 studies
• TOTAL PATIENTS INCLUDED IN REVIEW = 747 (566 ALND studies, 181 SLNB studies)
• SAMPLE RANGE ACROSS STUDIES: 12–143 patients
• KEY SAMPLE CHARACTERISTICS: Patients undergoing ALND or SLNB for breast cancer were included in the study; however, varying inclusion criteria existed between studies.

PHASE OF CARE: Diagnostic

The identification rates of ARM nodes and lymphatics during ALND ranged from 17%–91% and for SLNB, 38%–50%. The applicability in the clinical setting is questionable, given the low rates of ARM/lymphatics identification during both procedures. The broad ranges in ARM/lymphatic identification necessitates improvement in the procedure through standardization of procedure protocols. Metastatic involvement was reported higher in ARM nodes in patients with cancer burden that is extensive in the axilla (0%–43%) and in patients with SLN/ARM node convergence (up to 64%); therefore, further study to understand the connectivity of breast and arm lymphatics is necessary to improve the rate of clinical applicability with the ARM procedure. The outcome measure of lymphedema incidence with or without the ARM procedure varied with no conclusive evidence. Length of follow-up, small follow-up samples, and differences in lymphedema measures and definitions made the outcome measure relative to lymphedema incidence unattainable.

• Limited number of studies included
• No quality evaluation
• Low sample sizes
• Knowledge regarding the most commonly reported times to onset of lymphedema was not evident by the length of follow-up reported in most of the studies.
• No standardization
• No evaluation of evidence
• The need for standardization of study protocols are necessary to facilitate treatment fidelity and overall rigor of the research.

The implications for nursing would be in the area of patient education, if and when the ARM procedure becomes a standard of care. For the present, nurses need to be knowledgeable of clinical trials involving ARM.

To examine the effects of guided imagery on patient distress and symptoms during radiotherapy.

Patients received instruction on guided imagery during the first few days of radiotherapy treatment and participated in sessions with a nurse immediately prior to radiotherapy treatments. Sessions lasted about 30 minutes and involved relaxation and breathing exercises with visualization of a calming experience and setting. Patients were provided with a CD for home practice. Study measures were performed at baseline and at the end of radiotherapy treatments. Pre- and postsession pulse, blood pressure, and thermal biofeedback measures were obtained.

• The study reported a sample of 66 women; only 11 remained for the final measures.
• Mean age was 57 years (range 28–77).
• All patients had breast cancer and were undergoing active radiotherapy. Most were also receiving adjuvant chemotherapy and/or hormonal therapy.

• Single site
• Outpatient

A quasiexperimental design was used.

• Distress thermometer and visual analog scale (VAS) subscales
• EuroQol EQ-5D questionnaire
• Thermal biofeedback

EQ-5D subscale scores for anxiety and depression declined from a mean of 1.42 to 1.26 by the end of treatment (p = 0.01). There was a decline in overall distress scores (p = 0.04), but no significant changes occurred in depression, sleep, or fatigue scores. Patients showed immediate postsession reduction in respiratory rate and blood pressure but no significant differences in thermal biofeedback findings.

The findings suggest that relaxation and imagery can be helpful to patients during radiotherapy.

• The study had a small sample size, with less than 100 patients.
• The study had risks of bias due no control group, no blinding, and no random assignment.
• Patient withdrawals were 10% or greater.
• It is not known whether patients used the intervention between sessions.

Findings suggest that relaxation therapy and imagery can be helpful to patients during radiotherapy treatment; however, this study had substantial design limitations that limited the strength of the evidence. Relaxation and imagery, and particularly patients’ use of these techniques on their own, pose no patient risks and can be a practical intervention that is helpful to patients during active treatment.