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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 is currently recruiting participants.
Verified April 2012 by German Cancer Research Center
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01106820
First received: April 14, 2010
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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 Blind (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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Muscle strength measured at the IsoMed2000® [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • Cardiorespiratory fitness measured by ergospirometry [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • Biomarker in blood, urine, and saliva [ Time Frame: change between baseline and week 6 and 13 ] [ Designated as safety issue: No ]
  • Safety of resistance training during chemotherapy [ Time Frame: during intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106820

Contacts
Contact: Martina E Schmidt, Dr. +49 6221 422220 m.schmidt@dkfz.de
Contact: Joachim Wiskemann, Dr. +49 6221 56 38248 joachim.wiskemann@nct-heidelberg.de

Locations
Germany
German Cancer Research Center Recruiting
Heidelberg, Germany, 69120
Contact: Martina E Schmidt, Dr.     +49 6221 422220     m.schmidt@dkfz.de    
Principal Investigator: Karen Steindorf, Prof. Dr.            
Sponsors and Collaborators
German Cancer Research Center
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
  More Information

No publications provided by German Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01106820     History of Changes
Other Study ID Numbers: BEATE-1
Study First Received: April 14, 2010
Last Updated: April 5, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013