Macleod, N., Price, A., O'Rourke, N., Fallon, M., & Laird, B. (2014). Radiotherapy for the treatment of pain in malignant pleural mesothelioma: A systematic review. Lung Cancer (Amsterdam, Netherlands), 83, 133–138.
PHASE OF CARE: Late-effects and survivorship
APPLICATIONS: Palliative care
All of the evidence was reported as low with levels of 3 or 2 (specific grading scale not described). Response rates varied from 0%–69%. Six of the studies included were retrospective case series. Two studies did not document pain, and three studies did not use any clear measure of pain.
The effectiveness of radiotherapy for pain palliation in this group of patients is unclear.
Evidence regarding the effectiveness of radiotherapy for the treatment of pain from malignant pleural mesothelioma is lacking. Further well-designed research using valid tools for pain measurement is needed.
Machado Rocha, F.C., Stefano, S.C., De Cassia Haiek, R., Rosa Oliveira, L.M., & Da Silveira, D.X. (2008). Therapeutic use of cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: Systematic review and meta-analysis. European Journal of Cancer Care, 17, 431–443.
To use a systematic literature review and meta-analysis to evaluate interventions using Cannabis sativa in the treatment of chemotherapy-related nausea and vomiting
Databases searched were MEDLINE, Embase, PsycINFO, LILACS, and the Cochrane Collaboration Controlled Trials Register (12-2006).
Searched keywords were Medical Search Headings (MeSH) therapeutics, drug therapy, chemical and pharmacologic phenomena, neoplasms, antineoplastic and immunosuppressive therapy, marijuana abuse, cannabis, randomized controlled trials, and clinical trials.
Studies were included in the review if they
Studies were excluded from the review if they involved patients receiving radiotherapy.
The initial search yielded 12,749 papers. After scanning titles for inclusion, 735 abstracts were evaluated. Of these, 96 papers were reviewed and a final sample of 30 RCTs were included in the review. RCTs that were appropriate for meta-analysis numbered 13. Studies were rated for quality using the Cochrane Manual for methodological quality evaluation in terms of bias risk.
MacGregor, C.A., Canney, P.A., Patterson, G., McDonald, R., & Paul, J. (2005). A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer. European Journal of Cancer, 41, 708–714.
The study looked at soy supplements versus placebo for treatment of menopausal symptoms in participants with early breast cancer and hot flashes.
Participants were randomized to receive either two soy capsules or two identical placebo capsules twice daily for 12 weeks in a double-blind fashion. The soy capsules each contained 235 mg of soy extract with 17.5 mg of isoflavones. Total dose of isoflavones was 70 mg/day.
Seventy-two (72) participants with early breast cancer and hot flashes were randomized to 12 weeks of treatment with soy capsules or with placebo. To be considered a worthwhile treatment strategy, soy extract would need to benefit around half of the participants treated. Thus, 32 evaluable participants per arm were needed. The median age was 51 years. Any concomitant medications for preexisting disease were allowed.
The randomized double-blind controlled trial was stratified for initial sweating/flushing score (< 2, p = 2); age at randomization (younger than 50 years, older than 50 years); currently having adjuvant tamoxifen or after ovarian suppression (yes or no).
QOL and menopausal symptoms scores were assessed at baseline and weeks 4, 8, and 12. A four-question menopausal scale was developed for the study to assess control of menopausal symptoms measured by combined estimates of severity of sweats (day or night) and flushes.
There was no significant difference in menopausal symptoms between the placebo and soy capsule arms of the study.Toxicity was mild and primarily gastrointestinal. There was no significant difference in toxicity between the 2 arms.
Mace, J.R., Keohan, M.L., Bernardy, H., Junge, K., Niebch, G., Romeis, P., . . . Baker, L.H. (2003). Crossover randomized comparison of intravenous versus intravenous/oral mesna in soft tissue sarcoma treated with high-dose ifosfamide. Clinical Cancer Research, 9, 5829–5834.
To determine pharmacokinetics (PK) and efficacy of oral mesna
Patients were given IV mesna for the first dose and then randomized to IV or oral mesna for the following two doses. Crossover occurred at cycle two.
There were no significant differences in plasma PK between IV and oral. Rates of HC were not significant among IV and oral arms (3 of 16 for IV/IV/IV arm (90% CI 0.15 – 0.34) and 4 of 16 for IV/PO/PO arm (90% CI 0.23 – 0.52). Measurement of HC was not clearly defined.
Macann, A., Fua, T., Milross, C.G., Porceddu, S.V., Penniment, M., Wratten, C., ... Hockey, H.U. (2014). Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer: First report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study. International Journal of Radiation Oncology, Biology, Physics, 88(3), 572–579.
To evaluate domicile-based humidification on mucositis symptoms associated with radiation in patients with head and neck cancer
Inpatients were randomized 1:1. The control group (n = 100) received the institutional standard of care for managing mucositis (as defined by each institution), and the intervention group (n = 103) received the standard of care plus domicile-based humidification with the Fisher & Paykel Healthcare MR880 humidifier. The humidifier was set at 37°C and 100% relative humidity. 44 mg of vaporized water per liter of air was delivered via nasal prongs. Sensors were used for continuous feedback and to optimize delivery and prevent condensation. The rate of flow was selected to promote some leakage of moisture into the oral cavity and began at 25 L per minute. Flow was increased 30 L per minute if tolerated by the patient. Humidification began on the first day of radiation therapy with continuous use at night and additional use during the day. The intervention continued for 12 weeks. Patients who had a mucositis score ≥ 2 at week 12 continued the intervention until his or her score was < 2 or until week 16, whichever occurred first. The electronically recorded compliance was set with four hours of daily humidifier use as the benchmark. Data were recorded weekly until week 12 for all patients and weekly until week 16, or until mucositis scores were < 2, for some patients. Additional data were collected at weeks 12 and 20.
Randomized, controlled trial
High, medium, and low humidifier compliance rates were reported in 23, 20, and 60 patients, respectively. Per protocol (PP) patients were those in the medium and high compliance groups. The difference in compliance was significant between institutions (range = 0.11–0.74, mean = 0.37, p = 0.004). The mean number of hours the intervention device was used was 3.6 hours (range = 0–14 hours). Differences in the institutions' area under the curve (AUC) for mucositis scores ≥ 2 were significant (range = 6.87–11.87, p = 0.008). There was no difference in the AUC in CTCAE scores. There was a difference between groups in PP functional mucositis scores ≥ 2 (p = 0.009) and ≥ 3 (p = 0.006).
Humidification can decrease the severity of mucositis and decrease the time to healing of ulcerated mucositis. Unfortunately, there was a low rate of compliance with the home-based humidification intervention. Patients in the study cited the following reasons for disliking the intervention: dislike of high-flow rate, heat, plastic nasal interface odor or bore size, and noise during the night. The study also showed that patients who reported the highest satisfaction with the humidifier were those who had the most symptom relief from its use.
Patients who were compliant with the intervention saw a reduction in the severity of mucositis and faster healing of oral ulcers. The majority of patients enrolled, however, reported low compliance with the intervention for a variety of reasons. The use of a humidifier at home may appeal to some patients. Nurses can play an important role in assessing if patients are ready to make a life change that includes an intervention such as this one. Patients who were compliant with the intervention reported more symptom relief than patients who were not compliant.
Lyon, D. E., Schubert, C., & Taylor, A. G. (2010). Pilot study of cranial stimulation for symptom management in breast cancer. Oncology Nursing Forum, 37, 476–483.
To determine whether cranial electrical stimulation (CES) is feasible for symptom management in patients with breast cancer receiving chemotherapy and to examine the outcomes for reducing the symptoms of fatigue, depression, anxiety, pain, and sleep disturbances in these patients.
Symptom reports (on fatigue, depression, anxiety, pain, and sleep disturbances) were collected at baseline by a research associate and then weekly using an interactive voice response (IVR) phone system. Patients were trained on the use of the CES devices and were able to use them at a setting of 100 µA for up to sixty minutes per day. They began using the devices on the first day of their chemotherapy infusions. Patients receiving chemotherapy every two weeks used the CES device for a total of six weeks; those receiving chemotherapy every three weeks used them for a total of eight weeks. A follow-up interview was held after patients finished the protocol.
Multisite
Patients were undergoing the active treatment phase of care.
This was a prospective, double-blind, three-group, randomized, longitudinal pilot feasibility study.
Positive correlations existed between all symptoms, except pain and anxiety. Pain and fatigue symptoms were highly correlated with C-reactive protein.
CES appears to be a safe intervention during chemotherapy. This study showed that CES was a feasible and safe intervention during chemotherapy. It also showed positive correlations between several symptom management variables, but larger studies are needed to determine whether CES is effective for symptom management.
The study examined several symptoms seen in patients with breast cancer. Larger studies are needed to examine whether CES has a true effect on pain symptoms in patients with breast cancer.
Lyon, D., Kelly, D., Walter, J., Bear, H., Thacker, L., & Elswick, R.K. (2015). Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus, 4, 369-015-1151-z.
To examine the effects of cranial stimulation on symptoms
Women were randomly assigned to receive actual or sham cranial stimulation. The device passed biphasic electrical stimulation via ear lobe electrodes. The active device was preset to deliver maximum stimulation at 0.5 Hz and 100 µA, the lowest setting below the level of perception. The sham device was identical but did not transmit a current. Patients were instructed to use the device daily for one hour during chemotherapy treatment and for two weeks after treatment cessation. Symptom data were collected weekly, and patients completed logs to record stimulator use.
Double-blinded, randomized, sham-controlled trial
There were no statistically significant differences in levels of depression, anxiety, pain, fatigue, or sleep at any time point during the study. Symptom levels were low. Anxiety was highest at baseline and decreased over time. Depression and fatigue increased over time.
This study did not demonstrate any benefit of microcurrent cranial stimulation in the management of pain, anxiety, depression, fatigue, or sleep disturbance among women receiving chemotherapy for breast cancer.
Cranial stimulation did not benefit symptom management in this study.
Lyon, M.E., Jacobs, S., Briggs, L., Cheng, Y., Iris, & Wang, J. (2014). A longitudinal, randomized, controlled trial of advance care planning for teens with cancer: Anxiety, depression, quality of life, advance directives, spirituality. Journal of Adolescent Health, 54, 710–717.
To test the feasibility, acceptability, and impact of family-centered advanced care planning for adolescents with cancer
Adolescent/family dyads were randomized to intervention and control study arms. All participants received a baseline assessment and were provided with an advanced care planning educational brochure. Those in the intervention group had five sessions of assessments and interviews and three weekly sessions with a trained or certified facilitator to explore values and beliefs, have conversations, share decision making processes about palliative care and goals, and express fears, values, beliefs, and goals about death and dying. Study measures were obtained at baseline and at three months.
Randomized, controlled trial
Anxiety declined in all adolescents over time. Among families, anxiety declined in those in the control group but increased in families in the intervention group. Baseline depression was significantly lower in the intervention group and increased over time. There were no significant differences between groups from the group and time analysis. There were no significant differences between groups in quality of life results. There were no other differences based on group assignment.
The family-centered advance care planning intervention tested here did not demonstrate any benefits for patients or families in regard to anxiety, depression, or quality of life.
Advance care planning is an important component of care for patients with cancer and their families. However, it might not reduce the emotional effects of the cancer trajectory. This study had numerous limitations and did not find benefit in terms of reducing anxiety or depression. Additional well-designed studies are needed to confirm the findings shown here.
Lymphoedema Framework. (2006). International consensus: Best practice for the management of lymphoedema. London, UK: Medical Education Partnership. Retrieved from http://www.woundsinternational.com/pdf/content_175.pdf
TYPES OF PATIENTS ADDRESSED: Sample not described
PROCESS OF DEVELOPMENT: Study utilized previous Cochrane Systematic reviews along with current references to a United Kingdom national consensus on standards of practice for people at-risk for, or who have, lymphedema (LE)
Evidence weighed using the following classification:
Recommended for Practice
Complete decongestive therapy
Compression bandaging
Management of infection: Cellulitis/erysipelas
Exclude other causes of systemic infection, DVT, or dermatologic conditions such as eczema and contact dermatitis.
Begin antibiotics as soon as possible (recommended for practice).
During bed rest, elevate limb, administer appropriate analgesia, and increase fluid intake.
Avoid simple lymphatic drainage (SLD) and manual lymphatic drainage (MLD). If tolerated, continue compression at a reduced level or switch from compression garments to MLLB.
Avoid long periods without compression.
Likely to be Effective
Manual lymphatic drainage (C)
Prevention of infection: skin care
Benefits Balanced With Harm
Exercise
Prophylactic antibiotics: prevention of infection
Effectiveness not Established
Intermittent pneumatic compression (C)
Simple lymphatic drainage (SLD)
Surgery (limited evidence, carefully selected patients may benefit, more research needed)
Expert Opinion
Patient education
Measurement
Lyman, G.H., Kuderer, N.M., & Djulbegovic, B. (2002). Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: A meta-analysis. American Journal of Medicine, 112, 406–411.
The purpose of the study was to evaluate colony-stimulating factors (CSFs) administered prophylactically, before the onset of neutropenia or fever, compared with concurrent placebo or untreated controls not allowing any dose escalation.
MEDLINE, EMBASE, and Cochrane Library databases were searched, and hand searches of references from published reports were conducted.
Eight randomized, controlled trials (RCTs), including 1,144 patients receiving chemotherapy for solid tumors (n = 753) or malignant lymphomas (n = 391); studies of patients who were receiving high-dose therapy that required stem cell or bone marrow transplantation (BMT) support or who were being treated for acute or chronic leukemia were excluded.
The overall mean risk of febrile neutropenia was 51% among patients not receiving CSFs, and the overall mean risk of febrile neutropenia was 32% among patients receiving CSFs.
CSFs significantly reduced:
CSFs increased the risk of:
CSFs did not improve infection-related mortality.
The authors concluded that CSFs are effective in reducing the risk of febrile neutropenia, documented infections, and chemotherapy dose reductions or delays, but they increase the risk of bone pain. CSFs had no impact on infection-related mortality.