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

April 18, 2016 updated by: Karen Steindorf, German Cancer Research Center

Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

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
        • National Center for Tumor Diseases

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:

  • 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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Resistance training
Other: Supervised progressive resistance training
2x60 minutes per week for 12 weeks
ACTIVE_COMPARATOR: Relaxation training
Other: Supervised progressive muscle relaxation training (Jacobson method)
2x60 minutes per week for 12 weeks

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
Measure Description
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)
Quantity of FoxP3+ CD25+ regulatory T-cells
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Inflammatory parameter CRP, SAA and IL-6
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+)
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only)
Time Frame: change between baseline and week 13 (end of intervention)

immunmagnetic purification of the Treg (Selection by CD4 und CD25 expression; MACS-beads) by co-culturing of titrated Treg with 3H marked autologuous, polyclonal (anti CD3/CD28) activiated, conventional T-cells (CD4+, CD25+) and subsequent assessment of the proliferation of conventional T-cells.

Zur Bestimmung der Treg-Spezifität wurde eigens eine neue Methode entwickelt, die auf der signifikant erhöhten suppressiven Aktivität antigenspezifisch aktivierter Treg, gegenüber nicht aktivierten Treg, basiert.
change between baseline and week 13 (end of intervention)
Number of participants with lymphedema, pain, nausea, dyspnea, or tachycardia as a measure of safety of resistance training during radiotherapy.
Time Frame: events with onset or worsening during the 12-week intervention period are considered
events with onset or worsening during the 12-week intervention period are considered
Cognitive performance measured by the Trail-Making-Test
Time Frame: change between baseline and week 13 (end of intervention)
change between baseline and week 13 (end of intervention)
Toxicity of radiotherapy (acute radio dermatitis; LENT-SOMA classification for late effects)
Time Frame: acute toxicity during radio therapy and late effects 6 weeks after end of radio therapy are recorded
acute toxicity during radio therapy and late effects 6 weeks after end of radio therapy are recorded

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
National Center for Tumor Diseases, Heidelberg

Investigators

  • Principal Investigator: Karen Steindorf, Prof. Dr., German Cancer Research Center
  • Principal Investigator: Karin Potthoff, Dr., University Hospital 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

February 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (ESTIMATE)

November 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEST

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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