Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy (BENEFIT)

German Cancer Research Center

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Aerobic exercise; Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery; Other: Resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02999074

BENEFIT

Details and patient eligibility

About

The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated.

A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.

Enrollment: 183 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥ 18 years of Age
• Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
• Scheduled for neoadjuvant CTx (but not yet started)
• Confirmed hormone receptor and Her2 status
• Sufficient German language skills
• Willing to train at the exercise facilities twice per week

Exclusion criteria

• Any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures
• Engaging in systematic intense exercise training (at least 1h twice per week)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 3 patient groups

Resistance exercise

Active Comparator group

Treatment:

Other: Resistance exercise

Aerobic exercise

Active Comparator group

Treatment:

Other: Aerobic exercise

Waitlist control

Other group

Treatment:

Other: Usual care during neoadjuvant chemotherapy/Exercise after surgery