Dibble, S.L., Chapman, J., Mack, K.A., & Shih, A. (2000). Acupressure for nausea: Results of a pilot study. Oncology Nursing Forum, 27, 41-47.
To compare the effects of usual care (regular antiemetics) versus usual care plus acupressure training on nausea and its intensity in women receiving chemotherapy for breast cancer
The intervention involved finger acupressure bilaterally at the P6 and ST36 acupressure points located on the forearm and knee for a maximum of three minutes for each point every morning or as needed for nausea. Baseline and poststudy questionnaires and a daily log were used to collect data.
The study was conducted in two sites located in urban areas in the western United States: an outpatient oncology clinic in a major teaching medical center and a private outpatient oncology practice.
Significant differences existed between the two groups in regard to nausea experience (p < 0.01) and nausea intensity (p < 0.04) during the first 10 days of the chemotherapy cycle, with the acupressure group reporting less intensity and experience of nausea.
DiRenzo, N., Montanini, A., Mannina, D., Dondi, A., Muci, S., Mancuso, S., … Federico, M. (2011). Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL). Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 19(10), 1505-1510.
To evaluate the efficacy and safety of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT3) receptor antagonist, in patients with aggressive non-Hodgkin lymphoma receiving moderately emetogenic chemotherapy (MEC)-containing steroids
Patients received a single IV bolus of palonosetron (0.25 mg) over 30 minutes before administration of chemotherapy (day 1), and patients were assessed from day 1 through day 5. The antiemetic response was evaluated during the acute, delayed, and overall phases, as well on each day.
This multisite was conducted in Italy.
This was a prospective, open label, nonrandomized, phase II study.
A single dose of palonosetron is effective, tolerable, and safe in control of CINV in patients receiving MEC-regimen-containing steroids.
A single dose palonosetron infusion is a tolerable and safe option for patients receiving MEC-containing steroids. A single-dose palonosetron infusion could be less expensive in comparison to multiple administration of IV infusions of the first generation 5-HT3 RAs, which also could save time and required workforce.
Dhruva, A., Miaskowski, C., Abrams, D., Acree, M., Cooper, B., Goodman, S., & Hecht, F. M. (2012). Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. Journal of Alternative and Complementary Medicine, 18, 473–479.
To assess the feasibility and effects of pranayama (regulation and expansion of breath) among patients receiving chemotherapy. To test the efficacy of pranayama in alleviating common chemotherapy-associated symptoms (fatigue, sleep disturbance, stress, anxiety, and depression) and improving quality of life (QOL). To evaluate patients' responses to the use of pranayama in alleviating common chemotherapy-associated symptoms affecting QOL.
Participants were randomized 1:1 in blocks of four. The allocation sequence was generated by the study statistician and then transferred to sealed numbered envelopes. The study staff enrolled participants and implemented the allocation sequence, which was concealed from the study staff until study assignment. Blinding of participants was impossible due to the intervention, which consisted of a 60-minute class once per week taught by yoga instructors and twice daily home practice that totaled 20 to 30 minutes per day, along with usual care during two cycles of chemotherapy. The control group received only usual care during the initial cycle of chemotherapy, and the pranayama intervention along with usual care during the second cycle of chemotherapy.
Patients were undergoing the active treatment phase of care.
The study was a randomized, controlled trial.
Sixteen of 18 participants completed all study measures: eight from the control group and eight from the treatment group. The study intervention had no adverse effects. Increased yoga practice was associated with statistically significant reductions in sleep disturbance (p = 0.04) and anxiety (p = 0.04). The mental component of QOL approached statistical significance (p = 0.05).
This was the first study of a pure pranayama intervention for patients with cancer, and it demonstrated that yoga breathing is a feasible and safe intervention for this patient population. Any increase in the yoga breathing practice correlated with improvements of chemotherapy-associated symptoms and QOL. Researchers should confirm these findings by means of a larger study.
Among patients with cancer who are undergoing chemotherapy, pranayama breathing techniques may help decrease sleep disturbance and anxiety and increase the mental component of QOL. Pranayama breathing, supplemented with reminders during and between treatments, seems to be an intervention that is feasible for this group of patients.
Dhinakaran, M., Jain, K., Benjamin, K.E., Kaur, P., & Dhinakaran. (2014). Effect of complete decongestive therapy (CDT) in upper limb lymphedema in breast cancer patients. Indian Journal of Physiotherapy and Occupational Therapy, 8, 87–91.
To identify the long-term effect of complete decongestive therapy (CDT) to decrease lymphedema and enhance quality of life in patients after radical mastectomy with unilateral upper extremity lymphedema
Volume of the affected limb was decreased by 80.22 (95% confidence interval [CI] [–96.71, –63.73]) from baseline to the third month (p < 0.0001). Mean change in quality of life at the second month as compared to baseline was significant (69.95, 95% CI [66.49, 73.42], p < 0.0001).
CDT may be effective in reducing the volume in the lymphedema limb and in enhancing breast cancer survivors’ quality of life.
More rigorously designed studies are needed to examine the effectiveness of CDT in patients with lymphedema. Note that patients who underwent lumpectomy also developed lymphedema.
Dharmawardene, M., Givens, J., Wachholtz, A., Makowski, S., & Tjia, J. (2015). A systematic review and meta-analysis of meditative interventions for informal caregivers and health professionals. BMJ Supportive and Palliative Care. Advance online publication.
PHASE OF CARE: End of life care, various stages of diseases (dementia, advanced disease including cancer, children chronic illness) care
APPLICATIONS: Pediatrics, Elder care, Palliative care
Focusing on the outcomes for ICGs, the combined evidence from the controlled trials supports use of meditative interventions to minimize ICG’s depression, anxiety, and stress. Combined evidence from the pre- and postmeditative intervention studies supported their use in alleviating ICG burden. However, the insufficient study rigor and number prevent ed conclusions about the meditative interventions' effects on caregiver energy, fatigue, hope, confusion, and grief or life satisfaction. The insufficient number of studies prevents assessment of effect of meditation on caregivers’ capacity for decision making, patient advocacy, or resilience.
The effect of a meditative intervention on caregivers of patients with cancer should be explored with more studies using rigorous designs possessing higher statistical power. The initial data from this study indicate that a meditative intervention may benefit the ICGs of patients with various illnesses.
Devoogdt, N., Christiaens, M.R., Geraerts, I., Truijen, S., Smeets, A., Leunen, K., . . . Van Kampen, M. (2011). Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial. BMJ (Clinical Research Ed.), 343, d5326.
To determine the effect of manual lymph drainage (MLD) in addition to exercise compared to exercise alone for management of lymphedema in patients with breast cancer
After surgery, patients with axillary node dissection were recruited to the study and randomized to receive exercise, guidelines for self-care and MLD, or exercise and guidelines alone. MLD was begun one week after removal of axillary drains and 5 weeks after surgery and was provided for 20 weeks. All patients received the same guidelines and 30-minute individual exercise sessions. Standardized MLD sessions took half an hour, and patients received 40 treatments during the study period. Patient assessments were done at 1, 3, 6, and 12 months after surgery.
The study took place at a singe outpatient site in the Netherlands.
Patients were undergoing multiple phases of care.
The study used a single-blind randomized controlled trial design.
There were no differences between groups in incidence of arm lymphedema, time to lymphedema development, or maximal increase in arm circumference.
The addition of MLD to a program of patient guidelines and education and exercise did not have an effect on prevention of arm lymphedema in patients with breast cancer after axillary node dissection.
Findings show that the addition of MLD to a program of exercise and patient guidelines for self-management had no benefit to prevent lymphedema development.
Devine, E.C. (2003). Meta-analysis of the effect of psychoeducational interventions on pain in adults with cancer. Oncology Nursing Forum, 30(1), 75–89.
To obtain estimates of the effect of selected psychoeducational interventions on pain in patients with cancer
The search retrieved 50 studies. Authors eliminated 25 studies on the basis of inclusion and exclusion criteria. Authors did not describe the method of evaluation.
Most studies demonstrated that psychoeducational interventions had at least a small positive effect on pain in patients with cancer.
Further well-designed research in this area is needed. The complexity of cancer-related pain presents a number of challenges inherent in this research; authors outline these challenges. Psychoeducational interventions may be more acceptable to some patients than others, as high attrition rates suggest. In addition, rating pain is a subjective activity. The efficacy of an intervention may differ with cancer phase and with different pain severity. These factors should affect selection of intervention type.
Desport, J.C., Gory-Delabaere, G., Blanc-Vincent, M.P., Bachmann, P., Beal, J., Benamouzig, R., . . . Senesse, P. (2003). Standards, options and recommendations for the use of appetite stimulants in oncology (2000). British Journal of Cancer, 89(Suppl. 1), S98–S100.
To review the literature on the use of appetite stimulants in oncology by a multidisciplinary group established by the French National Federation of Cancer Centers
The group conducted a literature search of four databases (MEDLINE, CancerLit, Embase, and the Cochrane Library) using search phrases: appetite stimulants, anorexia/drug therapy, cachexia/drug, or appetite associated with neoplasms. The search yielded 55 reports of randomized controlled trials (RCTs) published between 1990–1999 that evaluated the appetite-stimulating effect of corticosteroids, synthetic progestogens, or other drugs.
The group defined standards, options, and recommendations for the use of appetite stimulants.
They also defined the level of evidence.
The primary outcome used in analysis of study results was anorexia. Secondary outcomes were improved quality of life, increase in body weight, increased food consumption, decrease in nausea and/or vomiting, and improvement in anthropometric and biologic parameters.
Corticosteroids
Corticosteroids were found to be effective appetite stimulants. Their level of evidence was B1 (good-quality evidence from randomized trials), but optimal dose and scheduling information was lacking.
Synthetic Progestogens
Megesterol acetate: Effective appetite stimulant (level B1) and beneficial effect on body weight (level B1). Minimum effective dose is 160 mg/day (level B1). Optimal dose is 480 mg/day (level C). No greater efficacy was seen with doses higher than 480 mg/day (level B1).*
Medroxyprogesterone acetate: Effective appetite stimulant (level B1). Effect on weight was not confirmed (level C). The group recommended more clinical trials to establish optimal dose and duration of therapy.
Cyproheptadine: May be an appetite stimulant, but adverse effects were reported (level C).
Dronabinol, metoclopramide, nandrolone, pentoxifylline: No appetite-stimulating effects were shown (level C). These should be used only in the setting of RCTs.
Hydrazine sulfate: Not an appetite stimulant (level A).
Corticosteroids and progestogens can be used in the treatment of anorexia in patients with cancer, especially in patients with advanced disease and with any type of cancer. Hydrazine sulfate should not be used.
* Data from trials completed after 1999 establish the safety and efficacy of higher doses of megesterol acetate.
de Souza Fêde, A. B., Bensi, C. G., Trufelli, D. C., de Oliveira Campos, M. P., Pecoroni, P. G., Ranzatti, R. P., . . . Del Giglio, A. (2007). Multivitamins do not improve radiation therapy-related fatigue: results of a double-blind randomized crossover trial. American Journal of Clinical Oncology, 30, 432–436.
Patients were randomized to two groups. Group A received the placebo for the first phase of the study and then switched to receiving multivitamins for the second phase. Group B received multivitamins for the first phase of the study and then switched to receiving placebo for the second phase. The multivitamins provided for patients were Centrum Silver tablets. To keep patients and researchers blinded, Centrum Silver tablets were crushed and offered to patients within capsules identical to those containing placebo. Randomization was centralized by a pharmacist to maintain the blinding of patients and investigators. Patient outcomes were assessed at baseline (phase I), at the time of switching (phase II), and right before the start of the last radiation treatment (phase III).
Patients were undergoing the active treatment phase of care.
This was a double-blind, randomized, crossover trial with two groups: multivitamin and placebo.
No significant changes were elicited in fatigue outcomes by the multivitamin intervention. When groups were compared at phase I, no significant differences were found in fatigue. At phase II, group A had a significantly lower rate of general and physical fatigue than group B (p = 0.035). The Chalder Fatigue Scale scores of both general and physical fatigue reflected a trend in the same direction (p = 0.048).
Deshmukh, V., Kulkarni, A., Bhargava, S., Patil, T., Ramdasi, V., Gangal, S., . . . Sardeshmukh, S. (2014). Effectiveness of combinations of Ayurvedic drugs in alleviating drug toxicity and improving quality of life of cancer patients treated with chemotherapy. Supportive Care in Cancer, 22, 3007–3015.
To assess the effectiveness of a combination of Ayurvedic drugs in alleviating cancer- and treatment-related symptoms
Patients initially were divided into two groups. Group 1 did not receive any Ayurvedic drugs. Patients in group 2 received Ayurvedic herbal combinations at various time points during chemotherapy. Within group 2, arm 1 received the same drugs and a full course of chemotherapy while arm 2 received the same drugs at the start of the sixth chemotherapy cycle and arm 3 received them after completing the sixth cycle. Treatment was continued for 16 weeks. Drugs used were maukitkyukta kamdudha (MKD) and mauktikyukta praval panchamruta (MPP) in all treatment arms. Arm 3 also received suvarnabhasmadi (SBD) according to clinician preference based on Eastern Cooperative Oncology Group scores. MKD and MPP at 250 mg each were given orally twice daily. SBD was given orally at a dose of 395 mg twice daily in cow’s ghee. Patients were followed for six months. Outcomes were measured after the first cycle of chemotherapy, after the sixth cycle of chemotherapy, and one month after the sixth cycle.
Prospective study
Patients in arm 1 of the treatment group showed the least symptom severity of all groups. However, there were no statistically significant differences between the groups in any outcome measure. Symptoms declined in all patients after the first chemotherapy cycle. There were no significant differences in other chemotherapy-related toxicities.
This study showed some interesting but insignificant differences in chemotherapy-associated symptoms between patients receiving Ayurvedic drugs throughout chemotherapy, patients receiving the experimental drugs at difference time points, and patients who did not receive any of these drugs. This study's findings did not show that Ayurvedic drugs were effective in reducing symptoms compared to controls overall. This report had numerous design and reporting limitations.
Little research has been done on the effects of Ayurvedic drug combinations among patients with cancer as a form of complementary and alternative medicine to manage treatment-related symptoms. This study did not demonstrate the efficacy of the particullar combination tested, and the study had several design and reporting flaws. Additional well-designed and clearly reported research for this type of intervention is needed to determine what role, if any, Ayurvedic drugs have for symptom management in cancer care.