Breast CancerBEATENCT01106820
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
A study testing Supervised progressive resistance training and Supervised progressive muscle relaxation training (Jacobsen method) in people with Breast Cancer and Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.
Trial 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 quality of life in breast cancer patients during chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer-related Fatigue
- What is being tested?
- Supervised progressive resistance training and Supervised progressive muscle relaxation training (Jacobsen method)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patient after lumpectomy or mastectomy, stage I-III
- adjuvant chemotherapy
- BMI at least 18
Who cannot join
- contraindication for exercise
- radiotherapy during intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Breast Cancer, Cancer-related Fatigue
- Being tested
- Supervised progressive resistance training, Supervised progressive muscle relaxation training (Jacobsen method)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised progressive resistance trainingOther
Supervised progressive resistance training
Supervised progressive muscle relaxation training (Jacobsen method)Other
Supervised progressive muscle relaxation training (Jacobsen method)
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Active comparator | Not described Receives: Other: Supervised progressive resistance training |
| Relaxation training | Active comparator | Not described Receives: Other: Supervised progressive muscle relaxation training (Jacobsen method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Measured: change between baseline and week 13 (end of intervention)
Secondary outcomes (6)
Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)
Measured: 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))
Measured: change between baseline and week 13 (end of intervention)
Muscle strength measured at the IsoMed2000®
Measured: change between baseline and week 13 (end of intervention)
Cardiorespiratory fitness measured by ergospirometry
Measured: change between baseline and week 13 (end of intervention)
Biomarker in blood, urine, and saliva
Measured: change between baseline and week 6 and 13
Number of patients with adverse events potentially related to the resistance training
Measured: during the 12-week exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
- Responsible party
- Sponsor
- Investigators
- Karen Steindorf, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106820
- Sponsor's protocol ID
- BEATE-1
- Acronym
- BEATE
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2010
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23103936Schmidt ME, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K. Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial. Int J Cancer. 2015 Jul 15;137(2):471-80. doi: 10.1002/ijc.29383. Epub 2014 Dec 16.
PubMed 25484317Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. 2014 Oct;53(10):1356-65. doi: 10.3109/0284186X.2014.899435. Epub 2014 May 16.
PubMed 24837860Scharhag-Rosenberger F, Kuehl R, Klassen O, Schommer K, Schmidt ME, Ulrich CM, Wiskemann J, Steindorf K. Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv. 2015 Dec;9(4):612-9. doi: 10.1007/s11764-015-0437-z. Epub 2015 Feb 26.
PubMed 25711667Koeppel M, Steindorf K, Schmidt ME, Rosenberger F, Wiskemann J. Variability in resistance training trajectories of breast cancer patients undergoing therapy. Support Care Cancer. 2024 Dec 10;33(1):12. doi: 10.1007/s00520-024-09001-4.
PubMed 39656317Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Schmidt ME, Wiskemann J, Johnson T, Habermann N, Schneeweiss A, Steindorf K. L-Thyroxine intake as a potential risk factor for the development of fatigue in breast cancer patients undergoing chemotherapy. Support Care Cancer. 2018 Aug;26(8):2561-2569. doi: 10.1007/s00520-018-4095-3. Epub 2018 Feb 14.
PubMed 29445858
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01106820
- Acronym / sponsor ID
- BEATE / BEATE-1
- Conditions
- Breast Cancer, Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Active comparator | Other: Supervised progressive resistance training |
| Relaxation training | Active comparator | Other: Supervised progressive muscle relaxation training (Jacobsen method) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- breast cancer patient after lumpectomy or mastectomy, stage I-III
- adjuvant chemotherapy
- BMI at least 18
Key exclusion criteria (2 listed)
- contraindication for exercise
- radiotherapy during intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised progressive resistance trainingSupervised progressive resistance training | Other | Resistance training |
| Supervised progressive muscle relaxation training (Jacobsen method)Supervised progressive muscle relaxation training (Jacobsen method) | Other | Relaxation training |
Primary outcome
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
Time frame: change between baseline and week 13 (end of intervention)
6 secondary outcomes
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)
Biomarker in blood, urine, and saliva
Time frame: change between baseline and week 6 and 13
Number of patients with adverse events potentially related to the resistance training
Time frame: during the 12-week exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Background: PubMed 23103936Schmidt 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.
- Results publication: PubMed 25484317Schmidt ME, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K. Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial. Int J Cancer. 2015 Jul 15;137(2):471-80. doi: 10.1002/ijc.29383. Epub 2014 Dec 16.
- Results publication: PubMed 24837860Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. 2014 Oct;53(10):1356-65. doi: 10.3109/0284186X.2014.899435. Epub 2014 May 16.
- Results publication: PubMed 25711667Scharhag-Rosenberger F, Kuehl R, Klassen O, Schommer K, Schmidt ME, Ulrich CM, Wiskemann J, Steindorf K. Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv. 2015 Dec;9(4):612-9. doi: 10.1007/s11764-015-0437-z. Epub 2015 Feb 26.
- Derived from this study: PubMed 39656317Koeppel M, Steindorf K, Schmidt ME, Rosenberger F, Wiskemann J. Variability in resistance training trajectories of breast cancer patients undergoing therapy. Support Care Cancer. 2024 Dec 10;33(1):12. doi: 10.1007/s00520-024-09001-4.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 29445858Schmidt ME, Wiskemann J, Johnson T, Habermann N, Schneeweiss A, Steindorf K. L-Thyroxine intake as a potential risk factor for the development of fatigue in breast cancer patients undergoing chemotherapy. Support Care Cancer. 2018 Aug;26(8):2561-2569. doi: 10.1007/s00520-018-4095-3. Epub 2018 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Steindorf, Prof. Dr. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised progressive resistance training and Supervised progressive muscle relaxation training (Jacobsen method) in people with Breast Cancer and Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (time frame: change between baseline and week 13 (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106820, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.