Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study.

Purpose: This study investigated the effect of additional prophylactic acupuncture during chemotherapy on quality of life and side effects compared to standard treatment alone in breast cancer patients. Methods: In a pragmatic trial, newly diagnosed breast cancer patients were randomized to additional acupuncture treatments over 6 months or standard care alone (control group). The primary outcome was the disease-specific quality of life (FACT-B). Twenty qualitative semi-structured interviews were conducted with ten patients from each group regarding their subjective experiences. Results: A total of 150 women (mean age 51.0 (SD 10.0) years) were randomized. For the primary endpoint, FACT-B total score after 6 months, no statistically significant difference was found between groups (acupuncture: 103.5 (95%, CI 88.8 to 107.2); control (101.4 (− 97.5 to 105.4); difference 2.0 (− 3.4 to 7.5) p = 0.458)). Qualitative content analyses showed that patients in the acupuncture group described positive effects on psychological and physical well-being. For both patient groups, coping strategies were more important than reducing side effects. Conclusions: Breast cancer patients receiving prophylactic acupuncture during chemotherapy did not show better quality of life in the questionnaires in contrast to the reported positive effects in the qualitative interviews. Coping strategies for cancer appear to be important. Trial registration: clinicaltrials.gov; NCT01727362. Prospectively registered 11 July 2012; https://clinicaltrials.gov/ct2/show/NCT01727362. The manuscript adheres to CONSORT guidelines. [ABSTRACT FROM AUTHOR]