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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by German Cancer Research Center.
Recruitment status was  Recruiting
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

April 14, 2010
April 5, 2012
April 2010
December 2012   (final data collection date for primary outcome measure)
Fatigue measured by Fatigue Assessment Questionnaire (FAQ) [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106820 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Cancer
  • Cancer-related Fatigue
  • Other: Supervised progressive resistance training
    Supervised progressive resistance training
  • Other: Supervised progressive muscle relaxation training (Jacobsen method)
    Supervised progressive muscle relaxation training (Jacobsen method)
  • Active Comparator: Resistance training
    Intervention: Other: Supervised progressive resistance training
  • Active Comparator: Relaxation training
    Intervention: Other: Supervised progressive muscle relaxation training (Jacobsen method)
Schmidt ME, Wiskemann J, Krakowski-Roosen H, Knicker AJ, Habermann N, Schneeweiss A, Ulrich CM, Steindorf K. Progressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: design and rationale of a randomized controlled trial (BEATE study). Contemp Clin Trials. 2013 Jan;34(1):117-25. doi: 10.1016/j.cct.2012.10.006. Epub 2012 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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
Germany
 
NCT01106820
BEATE-1
No
German Cancer Research Center
German Cancer Research Center
  • National Center for Tumor Diseases, Heidelberg
  • University Hospital Heidelberg
  • Central Institute of Mental Health, Mannheim
Not Provided
German Cancer Research Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP