[Osteopathy for chronic pain after breast cancer surgery: A monocentric randomised study]. / Étude randomisée monocentrique évaluant l'efficacité de l'ostéopathie dans la prise en charge des douleurs chroniques après chirurgie mammaire en oncologie.

Twenty-five to 65% of patients suffer from chronic pain after breast cancer. The treatment combines analgesic drugs and psychophysical techniques. HYPOTHESIS: Osteopathy improves the control of pain and the quality of life of patients. METHODS: This randomized prospective single center study allocated patients to the initiation of a standard analgesic treatment exclusively (arm A) or associated to osteopathy (arm B) between from 1 to 12months after surgery. MAIN OBJECTIVE: Intensity of pain (VAS at three months [j90]). SECONDARY OBJECTIVES: Pain (VAS) at 6 and 12 months, analgesic consumption, anxiety/depression (HADS), and Quality of life (QLQ-C30). Eighty patients were planned to observe a 2-point difference in VAS (5% bilateral alpha, 90% power). RESULTS: Twenty-eight patients (A: 14; B: 14, median age 50 years) were included from April 2011 to February 2014; the study was stopped due to a too slow recruitment. No difference in the VAS pain score between arms was observed at j90 (P=0.258), nor at 6 and 12 months. At j90, the HADS depression score was reduced in arm B (P=0.049). Improvement in the overall score of quality of life (P=0.015), and reduced pain sub-score (P=0.021) were observed at j90 in arm B. DISCUSSION: Patients are strongly seeking complementary therapies. Few studies exist. Our study has encountered major recruitment difficulties therefore limiting the interpretation of the results. Despite the absence of difference in the main objective, some other scores (QOL, depression) are noteworthy in favor of osteopathy. Further multicentric studies are needed.

Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.

PURPOSE: Lack of physical activity (PA), weight gain, and overweight have been associated with increased risk of recurrence and mortality after breast cancer diagnosis. We evaluated the feasibility of implementing an individualized exercise program and nutritional counseling during adjuvant treatment of localized invasive breast cancer. METHODS: Sixty-one patients eligible for adjuvant chemotherapy were randomized 2:1 to receive a 6-month program of weekly aerobic exercises associated with nutritional counseling (n = 41) or usual care with nutritional counseling (n = 20, one withdrawal). The primary endpoints were the proportion of patients compliant with two weekly supervised sessions and their overall adherence (i.e., proportion of supervised and unsupervised sessions completed versus planned sessions). RESULTS: Ten percent of patients in the intervention group were compliant with the two weekly supervised sessions for 6 months, but the overall median adherence rate was 85% of supervised and non-supervised sessions completed. Non-adherence was mainly due to intrinsic reasons (medical, organizational, psychological barriers). Adherence was positively associated with education and baseline PA level and inversely associated with baseline weight and tumor grade. No statistically significant benefits were observed in the intervention group, even if overall PA level and body composition improved and anthropometrics were maintained over time (p < 0.05). CONCLUSIONS: Overall, there was good adherence with the 6-month exercise program during adjuvant treatment for breast cancer, despite poor compliance to twice-weekly supervised sessions. This study highlights the need for flexible exercise modalities and innovative experimental design to reach patients who would most adhere and benefit from intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1.