Dr. Martina Schmidt, Prof. Dr. Karen Steindorf, Dr. Joachim Wiskemann, Prof. Dr. Friederike Rosenberger
Prof. Dr. Andreas Schneeweiss, Prof. Dr. Friedmann-Bette, Dr. med. Lorenz Lehmann
Exercise during neoadjuvant chemotherapy in breast cancer patients to improve therapy tolerance and tumor response
Scientific research has shown that targeted exercise during or after chemotherapy can lead to reduced side-effects (e.g. fatigue), to enhanced physical fitness and to improved quality of life. Only little, however, is known about what type and timing of the training are best.
It is also still unclear whether exercise accompanying chemotherapy has an influence on the outcome of the therapy. While observational studies have shown an improved disease-free survival in breast cancer patients who have been physically active, randomized controlled studies on this question are still lacking. However, recent results from secondary analyses of a randomized exercise intervention study as well as from small-scale pilot studies and preclinical studies using animal models, support the hypothesis that physical exercise concomitant to chemotherapy may enhance the cytotoxic effect of the therapy and may thus lead to an improved prognosis.
With the BENEFIT study we therefore aim to examine different types and start points of exercise interventions for their impact on tolerance and efficacy of chemotherapy as well as on physical fitness and quality of life.
Should the exercise program show to have a positive effect on tumor response or chemotherapy tolerance and compliance, this would be a strong argument for patients not to delay training but to engage in exercise as early as during neoadjuvant chemotherapy. Our study aims to contribute to the development of more specific individualized training recommendations for breast cancer patients in the future.
To this end we randomize breast cancer patients before the start of their neoadjuvant chemotherapy into three different training interventions: (1) resistance training concomitant to neoadjuvant chemotherapy; (2) aerobic training concomitant to neoadjuvant chemotherapy; or (3) 18-week resistance training after breast surgery. For each group, there will be two training sessions per week of about 45-60 minutes. Training will be supervised and guided by experienced therapists at Heidelberg or carried out at one of the cooperation centres of the OnkoAktiv network nearby.
Primary endpoint is the tumor size which will be measured along with other prognostic endpoints (i.a. CPS EG score, pCR) by the clinic carrying out the cancer treatment.
In addition, all participants are asked to fill out standardized questionnaires e.g. on fatigue, quality of life, sleep quality and depression. Physical performance levels (endurance and strength), sleep parameter (by ActiGraph) and cognitive functions are measured and blood and urine samples are taken to analyze various biomarkers. The examinations take place at the NCT before start of neoadjuvant chemotherapy (baseline) as well as 18 weeks and 6 months after breast surgery. Additionally, 9 weeks after start of chemotherapy as well as 1 year after breast surgery data will be collected by means of a questionnaire sent by mail.
Recruiting started in January 2016.
The BENEFIT study at a glance
- Goal of the study: improving chemotherapy tolerance and therapy response
- Target group: breast cancer patients with indication for neoadjuvant chemotherapy
- 3-arm study design with randomized allocation: resistance training concomitant to chemotherapy, aerobic training concomitant to chemotherapy, resistance training after breast surgery