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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
Information provided by (Responsible Party):
Karen Steindorf, German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01468766
First received: October 11, 2011
Last updated: August 13, 2014
Last verified: August 2014
  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 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 Intervention
Breast Cancer
Cancer-related Fatigue
Other: Supervised progressive resistance training
Other: Supervised progressive muscle relaxation training (Jacobson method)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantity of FoxP3+ CD25+ regulatory T-cells [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • Inflammatory parameter CRP, SAA and IL-6 [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+) [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • Specificity of FoxP3+ CD25+ regulatory T-cells (in a subgroup only) [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]

    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.


  • 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 ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Cognitive performance measured by the Trail-Making-Test [ Time Frame: change between baseline and week 13 (end of intervention) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468766

Locations
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
Principal Investigator: Karen Steindorf, Prof. Dr. German Cancer Research Center
Principal Investigator: Karin Potthoff, Dr. University Hospital Heidelberg
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: BEST
Study First Received: October 11, 2011
Last Updated: August 13, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014