Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy (BEST)

German Cancer Research Center

Status: Completed

Conditions: Breast Cancer; Cancer-related Fatigue

Treatments: Other: Supervised progressive resistance training; Other: Supervised progressive muscle relaxation training (Jacobson method)

Study type: Interventional

Funder types: Other

Identifiers

NCT01468766

BEST

Details and patient eligibility

About

The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed primary breast cancer, stage I-III, after lumpectomy or mastectomy, indication for adjuvant radiotherapy
• BMI: 18-40
• ability to understand and follow the study protocol

Exclusion criteria

• contraindication for exercise
• participation in the BEATE trial or another systematic resistance or relaxation training

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Resistance training

Active Comparator group

Treatment:

Other: Supervised progressive resistance training

Relaxation training

Active Comparator group

Treatment:

Other: Supervised progressive muscle relaxation training (Jacobson method)