Trial record 1 of 1 for:
NCT01468766
Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy (BEST)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01468766 |
|
Recruitment Status :
Completed
First Posted : November 9, 2011
Last Update Posted : April 19, 2016
|
Sponsor:
German Cancer Research Center
Collaborators:
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
Information provided by (Responsible Party):
Karen Steindorf, German Cancer Research Center
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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
Genetics Home Reference related topics:
Breast cancer
| 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 |
Primary Outcome Measures :
- Fatigue measured by Fatigue Assessment Questionnaire (FAQ) [ Time Frame: change between baseline and week 13 (end of intervention) ]
Secondary Outcome Measures :
- Quantity of FoxP3+ CD25+ regulatory T-cells [ Time Frame: change between baseline and week 13 (end of intervention) ]
- Inflammatory parameter CRP, SAA and IL-6 [ Time Frame: change between baseline and week 13 (end of intervention) ]
- Circulating lymphocytes subpopulations (CD4+, CD8+, CD56+) [ Time Frame: change between baseline and week 13 (end of intervention) ]
- 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.
- 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) ]
- 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) ]
- Muscle strength measured at the IsoMed2000® [ Time Frame: change between baseline and week 13 (end of intervention) ]
- Cardiorespiratory fitness measured by ergospirometry [ Time Frame: change between baseline and week 13 (end of intervention) ]
- 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 ]
- Cognitive performance measured by the Trail-Making-Test [ Time Frame: change between baseline and week 13 (end of intervention) ]
- 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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
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
| 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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| First Posted: | November 9, 2011 Key Record Dates |
| Last Update Posted: | April 19, 2016 |
| Last Verified: | April 2016 |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |