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Trial record 1 of 1 for:    NCT01468766
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Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy (BEST)

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ClinicalTrials.gov Identifier: NCT01468766
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
Information provided by (Responsible Party):
Karen Steindorf, German Cancer Research Center

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer-related Fatigue Other: Supervised progressive resistance training Other: Supervised progressive muscle relaxation training (Jacobson method) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
Study Start Date : February 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. Quantity of FoxP3+ CD25+ regulatory T-cells [ Time Frame: change between baseline and week 13 (end of intervention) ]
  2. Inflammatory parameter CRP, SAA and IL-6 [ Time Frame: change between baseline and week 13 (end of intervention) ]
  3. Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+) [ Time Frame: change between baseline and week 13 (end of intervention) ]
  4. 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.


  5. 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) ]
  6. 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) ]
  7. Muscle strength measured at the IsoMed2000® [ Time Frame: change between baseline and week 13 (end of intervention) ]
  8. Cardiorespiratory fitness measured by ergospirometry [ Time Frame: change between baseline and week 13 (end of intervention) ]
  9. 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 ]
  10. Cognitive performance measured by the Trail-Making-Test [ Time Frame: change between baseline and week 13 (end of intervention) ]
  11. 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 ]

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

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
Contacts and Locations
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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): NCT01468766


Locations
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Germany
National Center for Tumor Diseases
Heidelberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
Investigators
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Principal Investigator: Karen Steindorf, Prof. Dr. German Cancer Research Center
Principal Investigator: Karin Potthoff, Dr. University Hospital Heidelberg
More Information
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Publications of Results:

Other Publications:

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

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Responsible Party: Karen Steindorf, Prof. Dr. Karen Steindorf / Dr. Karin Potthoff, National Center for Tumor Diseases, Heidelberg, German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01468766    
Other Study ID Numbers: BEST
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases