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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106820
First Posted: April 20, 2010
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
German Cancer Research Center
  Purpose
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).

Condition Intervention
Breast Cancer Cancer-related Fatigue Other: Supervised progressive resistance training Other: Supervised progressive muscle relaxation training (Jacobsen method)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • Fatigue measured by Fatigue Assessment Questionnaire (FAQ) [ Time Frame: change between baseline and week 13 (end of intervention) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • Muscle strength measured at the IsoMed2000® [ Time Frame: 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) ]
  • Biomarker in blood, urine, and saliva [ Time Frame: 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 ]

Enrollment: 101
Study Start Date: April 2010
Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106820


Locations
Germany
German Cancer Research Center
Heidelberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Karen Steindorf, Prof. Dr. NCT Heidelberg
  More Information

Publications:
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01106820     History of Changes
Other Study ID Numbers: BEATE-1
First Submitted: April 14, 2010
First Posted: April 20, 2010
Last Update Posted: December 19, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms