Skip to main content
OpenTrials
Completed

NCT Number: NCT01468766

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer-related Fatigue Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Center for Tumor Diseases

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised progressive resistance training

Other

2x60 minutes per week for 12 weeks

Supervised progressive muscle relaxation training (Jacobson method)

Other

2x60 minutes per week for 12 weeks

Primary outcomes

  1. Fatigue measured by Fatigue Assessment Questionnaire (FAQ)

    Time frame: change between baseline and week 13 (end of intervention)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • National Center for Tumor Diseases, Heidelberg
  • University Hospital Heidelberg

Registry information

Official study title

Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial

Acronym: BEST

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 9, 2011
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.