Loudon, A., Barnett, T., Piller, N., Immink, M.A., & Williams, A.D. (2014). Yoga management of breast cancer-related lymphoedema: A randomised controlled pilot-trial. BMC Complementary and Alternative Medicine, 14, 214.
To determine how women with stage 1 breast cancer-related lymphedema (BCRL) are affected by yoga
Multi-center, randomized, controlled pilot trial using a parallel design with participants allocated to the intervention or control groups on a 1:1 ratio
At week 8, the intervention group had a greater decrease in tissue induration in the affected upper arm compared to the control group (p = 0.050) and a greater reduction in the symptom subscale for quality of life (p = 0.038). There was no difference in arm volume of lymphedema or extracellular fluid between groups at week 8. However, at week 12, arm volume increased more for the intervention group than the control group (p = 0.032).
The outcomes of this small pilot trial provided preliminary evidence that an eight-week Satyananda yoga intervention did not exacerbate lymphedema and improved tissue induration ing the affected upper arm as well as quality of life subscale symptoms. However, the fact that these improvements were not maintained at the one-month follow-up when arm volume was increased suggested that yoga needs to be ongoing. This is one of few studies that addresses tissue induration.
Yoga may reduce tissue induration in the upper arm affected by lymphedema and decrease its associated symptoms. However, additional research trials with longer durations, higher levels of lymphedema, and larger numbers are warranted before definitive conclusions can be made.
Lötzke, D., Wiedemann, F., Rodrigues Recchia, D., Ostermann, T., Sattler, D., Ettl, J., . . . Büssing, A. (2016). Iyengar-yoga compared to exercise as a therapeutic intervention during (neo)adjuvant therapy in women with stage I–III breast cancer: Health-related quality of life, mindfulness, spirituality, life satisfaction, and cancer-related fatigue. Evidence-Based Complementary and Alternative Medicine (eCAM), 2016, 5931816.
To test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with stages I–III breast cancer
In a randomized controlled trial (N =119) (with data from 92 used for data analyses), women with breast cancer undergoing oncological treatment were randomly enrolled in a yoga intervention (YI) (n = 45) or a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t0) and after the intervention (t1), as well as three months after finishing the intervention (t2) using standardized questionnaires.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled trial with active control
Statistically significant results were found on most functional scales of the EORTC, which indicated the spontaneous recovery of patients’ quality of life after chemotherapy and/or radiation. The global health, role, and social functioning of patients in both groups improved significantly, yet neither group significantly differed from the other in these variables. Fatigue, dyspnea, appetite loss, constipation, and diarrhea improved in both groups. For “nausea and vomiting” and “pain,” significant changes were observed over time. No difference existed in life satisfaction, cancer-related fatigue, spirituality, and mindfulness between the groups.
High drop out rate may be related to the number of measurements. One of the concerns was that patients in treatment were having difficulty with the exercise and yoga programs thought to be from the side effects of the treatment. Further study focusing on one or two areas would be beneficial.
The authors felt that this study may have been accepted by patients post-treatment or by using other forms of yoga. Self-care is becoming more common today, and yoga something you can do for yourself. Further investigation should be conducted to see how effective yoga is for patients with cancer.
Lorusso, V., Spedicato, A., Petrucelli, L., Saracino, V., Giampaglia, M., & Perrone, T. (2009). Single dose of palonosetron plus dexamethasone to control nausea, vomiting and to warrant an adequate food intake in patients treated with highly emetogenic chemotherapy (HEC): Preliminary results. Supportive Care in Cancer, 17, 1469–1473.
To evaluate the efficacy of a single-dose palonosetron plus dexamethasone to control emesis in patients receiving highly emetogenic chemotherapy (HEC) and to measure any reduction of calories consumption related to CINV
At baseline, nutritional evaluation subjective global assessment and assessment of appetite were done. Patients received a single bolus of 250 mcg palonosetron plus a single dose of 20 mg dexamethasone 30 minutes prior to chemotherapy. Subjects recorded emesis, nausea, use of rescue medication, and food intake in daily diaries. Amount of food intake was quantified with the aid of pictures of standard portions.
The study was conducted at a single site.
All patients were in active treatment.
This was a prospective trial (noncomparative, single-arm study).
Palonosetron was able to prevent both acute and delayed vomiting and nausea in most patients treated with HEC. A strong, significant relationship was found between the presence of nausea and lower caloric intake.
Lorusso, V., Giampaglia, M., Petrucelli, L., Saracino, V., Perrone, T., & Gnoni, A. (2012). Antiemetic efficacy of single-dose palonosetron and dexamethasone in patients receiving multiple cycles of multiple day-based chemotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20, 3241–3246.
To assess the efficacy of a single dose of palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) and guarantee an adequate food intake in patients receiving several cycles of multiple-day-based chemotherapy
Patients with advanced cancer but without a compromised nutritional status (bone mass > 18.5) receiving multiple cycles of multiple days (MD-CT) were treated with 0.25 mg palonosetron over 30 seconds and 20 mg dexamethasone 30 minutes prior to chemotherapy. Patients recorded the number and intensity of emesis episodes, use of rescue medication, and the time and amount of daily food intake including pictures when available.
This study was conducted at a single site at a hospital in Lecee, Italy.
This was a prospective, uncontrolled trial.
A direct correlation exists between mild nausea and significant decrease in food intake. Patients can easily become malnourished. Nurses need to assess closely for nausea, using a Likert-type scale and weight loss and malnutrition.
Palonosetron and dexamethasone can achieve high control of CINV during multiple days and multiple cycles of HEC. Nurses need to use instruments like the subjective global assessment (SGA) used in this study to better identify patients at risk for malnourishment rather than reyling solely on body mass index (BMI).
Lorusso, D., Ferrandina, G., Greffi, S., Gadducci, A., Pignata, S., Tateo, S. … Scambia, G. (2003). Phase III multicenter randomized trial of amifostine as cytoprotectant in first-line chemotherapy in ovarian cancer patients. Annals of Oncology, 14, 1086–1093.
Patients receiving carboplatin (area under the curve [AUC] 5 mg per minute/ml) and 175 mg/m2 paclitaxel were randomly assigned to receive 910 mg/m2 IV amifostine 30 minutes prior to carboplatin.
The study was conducted between April 1999 and July 2001.
This was a phase III, multicenter, randomized trial.
A significant difference was found in grade 3-4 mucositis (4.7% in the amifostine group versus 15.4% in the control group, p < 0.0001).
Loprinzi, C.L., Qin, R., Dakhil, S.R., Fehrenbacher, L., Flynn, K.A., Atherton, P., . . . Grothey, A. (2014). Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). Journal of Clinical Oncology, 32, 997–1005.
To provide a definitive test of the effectiveness of calcium and magnesium in decreasing oxaliplatin-induced neurotoxicity
Patients randomly were assigned to receive intravenous calcium gluconate and magnesium sulfate at 1 g each in 100 ml of D5W over the course of 30 minutes immediately prior to and after each dose of oxaliplatin. Patients in the control group received a placebo that appeared identical to the study drug with the same administration timing. A third group was administered calcium and magnesium before chemotherapy and a placebo after infusion. Patients with adenocarcinoma of the colon scheduled to receive 12 cycles of FOLFOX chemotherapy including 85 mg/m2 oxaliplatin every two weeks were considered for participation. Oxaliplatin dose modifications were not prescribed by the study, but dosage changes or delays were provided as recommendations. Study measures were obtained at each cycle of chemotherapy.
Three-group, double-blinded, placebo-controlled, randomized trial
There were no significant differences between the three study arms on the EORTC-QLQ CIPN20 sensory or motor neuropathy scales. There were no significant differences in neurotoxicity assessment using the CTCAE to determine time till grade 2 neurotoxicity or incidence of grade 2 symptoms. A subgroup analysis did not show evidence of benefit in groups according to age, sex, disease stage, or specific FOLFOX regimen. There were no differences in acute or chronic symptoms.
The findings of this study do not support the use of intravenous calcium gluconate and magnesium sulfate to prevent oxaliplatin-induced neuropathy.
This large, well designed trial showed no benefit of the use of a calcium gluconate and magnesium sulfate infusions to prevent peripheral neuropathy in patients receiving FOLFOX. The authors of this study state that as many as 50% of practitioners continue to use this intervention, and resources such as UpToDate suggest consideration of this intervention. Nurses can advocate that calcium gluconate and magnesium sulfate not be used for the prevention of peripheral neuropathy given the lack of evidence for its efficacy. This can save time and expense in treatment for patients receiving this type of chemotherapy. Additional similar research may be needed to examine this treatment's effects in patients at risk for peripheral neuropathy related to other chemotherapeutic agents.
Loprinzi, C.L., Kugler, J.W., Sloan, J.A., Mailliard, J.A., LaVasseur, B.I., Barton, D.L., … Christensen, B.J. (2000). Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet, 356, 2059–2063.
Assess more definitively than previous studies the efficacy and toxicity of various doses of venlafaxine for treatment of hot flashes in the breast cancer survivor
Participants were assigned to placebo (n = 56), or venlafaxine 37.5 mg daily (n = 56), 75 mg daily (n = 55), or 150 mg daily (n = 54).
Patients eligible for this trial were 221 women who had a history of breast cancer or who were concerned about taking estrogen therapy for fear of developing breast cancer.
Double-blind, placebo-controlled, randomized trial
It was calculated that a sample size of 50 patients per group would provide 80% power to detect differences in average hot-flash activity of standard deviation (SD) 0–6 (1–2 hot flashes per day, a score of 3 units, or a 21% fall from baseline) with a type 1 error rate of 5%.
Of the 229 patients who joined the study, 191 had data evaluable over the whole study period (50 from the placebo group, 49 from the venlafaxine 37.5 mg group, 43 from the venlafaxine 75 mg group, and 49 from the venlafaxine 150 mg group). After week 4 of treatment, median hot flash scores were reduced from baseline by 27%, 37%, 61%, and 61%, respectively, in the four groups. Frequencies of some side effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group.
The trial suggests that venlafaxine can alleviate hot flashes and that the most appropriate dose for this indication is 75 mg.
Missing data were handled in several ways as a sensitivity analysis of the robustness of the results in relation to the missing data. Less than 10% of possible data were missing, and the results were consistent across a series of analyses by various imputation methods.
The study makes mention that venlafaxine may also be effective against hot flashes in men who have undergone androgen deprivation therapy for prostate cancer.
Loprinzi, C.L., Michalak, J.C., Quella, S.K., O’Fallon, J.R., Hatfield, A.K., Nelimark, R.A., … Oesterling, J.E. (1994). Megestrol acetate for the prevention of hot flashes. New England Journal of Medicine, 331, 347–352.
The study was done to assess the efficacy and short-term toxicity of low-dose megestrol acetate as a treatment for hot flashes in women with breast cancer and in men who had undergone androgen-deprivation therapy for prostate cancer.
Subjects were randomly assigned to receive megestrol 20 mg twice a day for 4 weeks followed by placebo for 4 weeks.or placebo for 4 weeks then megestrol for 4 weeks. Subjects received no medication for the first 7 days.
Of the enrolled subjects, 163 cpmpleted the study. They included women with a history of breast cancer and men who had undergone surgical or medical orchiectomy. All had at least one hot flash per month. Women were stratified according to duration of hot flashes (9 months cut point). Men were stratified by medical or surgical orchiectomy and duration of androgen ablation.
The study was a double-blind, randomized, crossover trial.
Participants kept hot flash diaries, recording the number and severity of hot flashes each day. They also recorded appetite changes, fluid retention, and vaginal problems.
During the first 4 week medication period, megestrol was associated with decreased frequency of hot flashes for both men and women. Crossover analysis was not performed because of carryover effects of medication.
There was an insufficient washout period to allow for crossover analysis.
Loprinzi, C.L., Sloan, J., Stearns, V., Slack, R., Iyengar, M., Diekmann, B., … Novotny, P. (2009). Newer antidepressants and gabapentin for hot flashes: An individual patient pooled analysis. Journal of Clinical Oncology, 27, 2831–2837.
Efficacy and side-effects of three relatively low gabapentin doses in comparison to placebo.
Randomized to:
Outpatient oncology centers
Double-blind, placebo-controlled.
Hot flash frequencies and severities were recorded daily for a baseline week and for four weeks while taking the study medication; symptom experience diaries were completed weekly for five weeks; 30-item Profile of Mood States–Brief was completed at the end of the baseline week and the end of four weeks of treatment.
By the fourth treatment week, mean hot flash scores decreased from baseline in the placebo group by 4.1 units. They also decreased in the three increasing dose gabapentin groups by 3.2, 4.6, and 7.0 units. No significant difference was reported in the three combined gabapentin arms versus placebo: Wilcoxon rank-sum p values for change in hot flash scores and frequencies after four weeks of treatment were 0.10 and 0.02 comparing the highest dose gabapentin arm to the placebo arm, respectively.
Short follow-up period
Loprinzi, C. L., Kugler, J. W., Barton, D. L., Dueck, A. C., Tschetter, L. K., Nelimark, R. A., . . . Jaslowski, A. J. (2007). Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5. Journal of Clinical Oncology, 25, 308-312.
To determine the effectiveness of Gabapentin in combination with an antidepressant for the treatment of hot flashes.
Women must have been on a stable dose of antidepressant for the tx of hot flashes. In week one, patients completed a hot flash diary. In the second week, patients took 300 mg gabapentin at bedtime for 3 days, then twice daily for 3 days, then 3 times a day for 22 days. In one arm of the study patients remained on their previous dose of antidepressant and in the other arm patients weaned off antidepressants over 7-10 days and physician discretion was allowed. Patients completed a daily hot flash diary for 4 week and a weekly symptom assessment.
SITE Single site SETTING TYPE Outpatient LOCATION USA
PHASE OF CARE Late effects and survivorship
RCT
Both groups experienced a reduction in hot flashes: gabapentin = 60% reduction (95% CI, 33%-73%) and gabapentin plus antidepressant = 56% reduction (95% CI, 26%-71%)No difference between groups in hot flash scores or frequency from baseline to 4 weeks in either arm. No difference in toxicities reported by either arm. No difference in QOL in either arm.
This trial failed to demonstrate that the combination of gabapentin with antidepressants is more effective to reduce the number of hot flashes experienced by breast cancer survivors.
Risk of bias (no control group)
Risk of bias (no blinding)
Risk of bias(sample characteristics)
Other limitations/*explanation All breast cancer patients, no placebo arm
The combination of gabapentin plus antidepressant does not appear to be an effective regimen to decrease hot flashes in breast cancer survivors