Skip to main content
OpenTrials
Completed

NCT Number: NCT01106820

Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life

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 quality of life in breast cancer patients during chemotherapy. 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer-related Fatigue Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

German Cancer Research Center

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • breast cancer patient after lumpectomy or mastectomy, stage I-III
  • adjuvant chemotherapy
  • BMI at least 18

Exclusion criteria

  • contraindication for exercise
  • radiotherapy during intervention period

Treatment and study plan

Supervised progressive resistance training

Other

Supervised progressive resistance training

Supervised progressive muscle relaxation training (Jacobsen method)

Other

Supervised progressive muscle relaxation training (Jacobsen method)

Primary outcomes

  1. Fatigue measured by Fatigue Assessment Questionnaire (FAQ)

    Time frame: change between baseline and week 13 (end of intervention)

Secondary outcomes

  1. Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)

    Time frame: change between baseline and week 13 (end of intervention)

  2. Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))

    Time frame: change between baseline and week 13 (end of intervention)

  3. Muscle strength measured at the IsoMed2000®

    Time frame: change between baseline and week 13 (end of intervention)

  4. Cardiorespiratory fitness measured by ergospirometry

    Time frame: change between baseline and week 13 (end of intervention)

  5. Biomarker in blood, urine, and saliva

    Time frame: change between baseline and week 6 and 13

  6. Number of patients with adverse events potentially related to the resistance training

    Time frame: during the 12-week exercise intervention

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Central Institute of Mental Health, Mannheim
  • National Center for Tumor Diseases, Heidelberg
  • University Hospital Heidelberg

Registry information

Official study title

Progressive Resistance Training vs. Relaxation for Breast Cancer Patients During Chemotherapy: A Randomized Controlled Intervention Trial to Evaluate the Biological Mechanisms and Effects of Resistance Training on Fatigue and Quality of Life

Acronym: BEATE

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Apr 20, 2010
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.