Breast NeoplasmNCT00591747
Strength Training for Older Breast Cancer Survivors
A study testing Resistance Exercise and Flexibility Training in people with Breast Neoplasm and Osteoporosis, Postmenopausal, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Breast Neoplasm, Osteoporosis, Postmenopausal
- What is being tested?
- Resistance Exercise and Flexibility Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jun 2011
- 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 50 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with early stage breast cancer at age of 50 or older
- Completed adjuvant therapy, radiation +/- chemotherapy but selective estrogen receptor modulators (SERMS), (aromatase inhibitors (AIs) ok) at least 1 year prior to enrollment
Who cannot join
- Cognitive difficulties that preclude answering the survey questions, participating in performance testing or giving informed consent
- Diagnosed osteoporosis
- Current regular participation in planned impact activities or resistance training (more than 2 times a week for 30 minutes at a time)
- Medication that contraindicates participation in moderate intensity strength training or previous use of medications known to affect bone metabolism
- Movement or neurologic disorder, not including chemo-induced peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether physical activity and exercise interventions affect long-term symptoms, physical fitness and function, and body composition of older breast cancer survivors. Due to the combined effects of breast cancer, related treatments and aging it is likely that exercise is even more beneficial for older breast cancer survivors than for younger survivors. Along with the cancer-related symptom of fatigue common to cancer survivors, older survivors face age-related declines in bone and muscle mass, muscle strength, bone health and physical function (gait and balance) that are likely exacerbated by reduced physical activity in survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training is specifically suited to reverse or slow age-related declines in bone, muscle, strength and function and has shown promise to reduce cancer-related fatigue. However, no controlled trials of strength training in older breast cancer survivors have been conducted.
- Conditions
- Breast Neoplasm, Osteoporosis, Postmenopausal
- Being tested
- Resistance Exercise, Flexibility Training
- Keywords
- randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms
- Medical subject headings
- Breast Neoplasms, Osteoporosis, Postmenopausal, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
Flexibility TrainingBehavioural
60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Progressive resistance training program 3 times a week for 12 months Receives: Behavioral: Resistance Exercise |
| 2 | Active comparator | Flexibility training 3 times a week for 12 months Receives: Behavioral: Flexibility Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue
Measured: 12 months
Secondary outcomes (1)
Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startNov 2005
- Primary completionJan 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Kerri M Winters, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591747
- Sponsor's protocol ID
- 1836
- Other IDs
- 050106
- Status last verified
- May 2015
- First submitted
- 31 Dec 2007
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winters-Stone KM, Dobek J, Nail L, Bennett JA, Leo MC, Naik A, Schwartz A. Strength training stops bone loss and builds muscle in postmenopausal breast cancer survivors: a randomized, controlled trial. Breast Cancer Res Treat. 2011 Jun;127(2):447-56. doi: 10.1007/s10549-011-1444-z. Epub 2011 Mar 19.
PubMed 21424279Winters-Stone KM, Dobek J, Bennett JA, Nail LM, Leo MC, Schwartz A. The effect of resistance training on muscle strength and physical function in older, postmenopausal breast cancer survivors: a randomized controlled trial. J Cancer Surviv. 2012 Jun;6(2):189-99. doi: 10.1007/s11764-011-0210-x. Epub 2011 Dec 23.
PubMed 22193780Dobek J, Winters-Stone KM, Bennett JA, Nail L. Musculoskeletal changes after 1 year of exercise in older breast cancer survivors. J Cancer Surviv. 2014 Jun;8(2):304-11. doi: 10.1007/s11764-013-0313-7. Epub 2013 Dec 7.
PubMed 24317968Winters-Stone KM, Leo MC, Schwartz A. Exercise effects on hip bone mineral density in older, post-menopausal breast cancer survivors are age dependent. Arch Osteoporos. 2012;7(1-2):301-6. doi: 10.1007/s11657-012-0071-6. Epub 2012 Mar 20.
PubMed 23225299Ernst 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 39606939Winters-Stone KM, Wood LJ, Stoyles S, Dieckmann NF. The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153. doi: 10.1158/1055-9965.EPI-17-0766. Epub 2017 Nov 15.
PubMed 29141853
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training for Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00591747
- Acronym / sponsor ID
- 1836
- Conditions
- Breast Neoplasm, Osteoporosis, Postmenopausal
- Keywords
- randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Nov 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jan 2008 (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.
Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether physical activity and exercise interventions affect long-term symptoms, physical fitness and function, and body composition of older breast cancer survivors. Due to the combined effects of breast cancer, related treatments and aging it is likely that exercise is even more beneficial for older breast cancer survivors than for younger survivors. Along with the cancer-related symptom of fatigue common to cancer survivors, older survivors face age-related declines in bone and muscle mass, muscle strength, bone health and physical function (gait and balance) that are likely exacerbated by reduced physical activity in survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training is specifically suited to reverse or slow age-related declines in bone, muscle, strength and function and has shown promise to reduce cancer-related fatigue. However, no controlled trials of strength training in older breast cancer survivors have been conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Resistance ExerciseProgressive resistance training program 3 times a week for 12 months |
| 2 | Active comparator | Behavioral: Flexibility TrainingFlexibility training 3 times a week for 12 months |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with early stage breast cancer at age of 50 or older
- Completed adjuvant therapy, radiation +/- chemotherapy but selective estrogen receptor modulators (SERMS), (aromatase inhibitors (AIs) ok) at least 1 year prior to enrollment
Key exclusion criteria (5 listed)
- Cognitive difficulties that preclude answering the survey questions, participating in performance testing or giving informed consent
- Diagnosed osteoporosis
- Current regular participation in planned impact activities or resistance training (more than 2 times a week for 30 minutes at a time)
- Medication that contraindicates participation in moderate intensity strength training or previous use of medications known to affect bone metabolism
- Movement or neurologic disorder, not including chemo-induced peripheral neuropathy
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 |
|---|---|---|
| Resistance Exercise60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months | Behavioural | 1 |
| Flexibility Training60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home. | Behavioural | 2 |
Primary outcome
Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue
Time frame: 12 months
1 secondary outcome
Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur
Time frame: 12 months
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 28 May 2015.
- Results publication: PubMed 21424279Winters-Stone KM, Dobek J, Nail L, Bennett JA, Leo MC, Naik A, Schwartz A. Strength training stops bone loss and builds muscle in postmenopausal breast cancer survivors: a randomized, controlled trial. Breast Cancer Res Treat. 2011 Jun;127(2):447-56. doi: 10.1007/s10549-011-1444-z. Epub 2011 Mar 19.
- Results publication: PubMed 22193780Winters-Stone KM, Dobek J, Bennett JA, Nail LM, Leo MC, Schwartz A. The effect of resistance training on muscle strength and physical function in older, postmenopausal breast cancer survivors: a randomized controlled trial. J Cancer Surviv. 2012 Jun;6(2):189-99. doi: 10.1007/s11764-011-0210-x. Epub 2011 Dec 23.
- Results publication: PubMed 24317968Dobek J, Winters-Stone KM, Bennett JA, Nail L. Musculoskeletal changes after 1 year of exercise in older breast cancer survivors. J Cancer Surviv. 2014 Jun;8(2):304-11. doi: 10.1007/s11764-013-0313-7. Epub 2013 Dec 7.
- Results publication: PubMed 23225299Winters-Stone KM, Leo MC, Schwartz A. Exercise effects on hip bone mineral density in older, post-menopausal breast cancer survivors are age dependent. Arch Osteoporos. 2012;7(1-2):301-6. doi: 10.1007/s11657-012-0071-6. Epub 2012 Mar 20.
- 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 29141853Winters-Stone KM, Wood LJ, Stoyles S, Dieckmann NF. The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153. doi: 10.1158/1055-9965.EPI-17-0766. Epub 2017 Nov 15.
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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.
Kerri M Winters, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Flexibility Training in people with Breast Neoplasm and Osteoporosis, Postmenopausal, run by OHSU Knight Cancer Institute at 1 site in United States.
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 2 inclusion and 5 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 28 May 2015. 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 United States. 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?
Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue (time frame: 12 months). 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 NCT00591747, which also lists 6 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 28 May 2015.