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

December 16, 2016 updated by: German Cancer Research Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • German Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resistance training
Other: Supervised progressive resistance training
Supervised progressive resistance training
Active Comparator: Relaxation training
Other: Supervised progressive muscle relaxation training (Jacobsen method)
Supervised progressive muscle relaxation training (Jacobsen method)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
change between baseline and week 13 (end of intervention)
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)
change between baseline and week 13 (end of intervention)
Muscle strength measured at the IsoMed2000®
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Cardiorespiratory fitness measured by ergospirometry
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Biomarker in blood, urine, and saliva
Time Frame: change between baseline and week 6 and 13
change between baseline and week 6 and 13
Number of patients with adverse events potentially related to the resistance training
Time Frame: during the 12-week exercise intervention
during the 12-week exercise intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

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

Investigators

  • Principal Investigator: Karen Steindorf, Prof. Dr., NCT Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEATE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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