Breast NeoplasmNCT00659906
Optimizing Body Composition & Health After Breast Cancer
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
The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength training exercise to stretching and relaxation exercise (control) on body composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function (strength, power, gait, balance and… Read more about this study
- Who is it for?
- Any age, 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
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed breast cancer stage I-IIIa
- Completion of a chemotherapy regimen within the previous 5 years
- Premenopausal status (9-12 menstrual cycles/year) at the initiation of chemotherapy
- Complete absence of menstrual cycles for at least 6 months and within one year after starting chemotherapy OR confirmed menopause by blood tests conducted in the last 12 months prior to enrollment.
Who cannot join
- Presence of any known metastases
- Clinically defined osteoporosis
- Current or previous use of medications known to affect bone metabolism
- Current regular participation (>2x/wk for at least 30 min/session) in planned impact activities (i.e., volleyball, basketball), or resistance training
- A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength training exercise to stretching and relaxation exercise (control) on body composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function (strength, power, gait, balance and self-report physical function and symptoms) in women who experienced premature menopause from chemotherapy for breast cancer.
Read the detailed description
As a result of treatment, breast cancer survivors typically experience unhealthy changes in body composition (bone, muscle and fat). Treatments disrupt normal bone and energy balance resulting in bone and muscle wasting and fat gain. Premenopausal women are at greatest risk for these declines because most are thrust into early menopause from chemotherapy. Hormone manipulation therapy (i.e., tamoxifen or arimidex) may further affect these tissues. Exercise can prevent bone and muscle loss and promote fat loss. However, the ability of exercise to reverse unfavorable changes in all components of body composition in women experiencing early menopause from breast cancer treatment has not been specifically studied.
- Conditions
- Breast Neoplasm, Osteoporosis, Postmenopausal
- Being tested
- Resistance Exercise, Flexibility Training
- Keywords
- randomized clinical trial, 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.
Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.
Measured: 12 months
Secondary outcomes (1)
Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms
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 posted17 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Kerri M Winters, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659906
- Sponsor's protocol ID
- 621
- Status last verified
- May 2015
- First submitted
- 11 Apr 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winters-Stone KM, Dobek J, Nail LM, Bennett JA, Leo MC, Torgrimson-Ojerio B, Luoh SW, Schwartz A. Impact + resistance training improves bone health and body composition in prematurely menopausal breast cancer survivors: a randomized controlled trial. Osteoporos Int. 2013 May;24(5):1637-46. doi: 10.1007/s00198-012-2143-2. Epub 2012 Sep 21.
PubMed 22996743Winters-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
- Optimizing Body Composition & Health After Breast Cancer
- ClinicalTrials.gov ID
- NCT00659906
- Acronym / sponsor ID
- 621
- Conditions
- Breast Neoplasm, Osteoporosis, Postmenopausal
- Keywords
- randomized clinical trial, cancer survivor, bone health, body composition, signs and symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Apr 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.
The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength training exercise to stretching and relaxation exercise (control) on body composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function (strength, power, gait, balance and self-report physical function and symptoms) in women who experienced premature menopause from chemotherapy for breast cancer.
Detailed description
As a result of treatment, breast cancer survivors typically experience unhealthy changes in body composition (bone, muscle and fat). Treatments disrupt normal bone and energy balance resulting in bone and muscle wasting and fat gain. Premenopausal women are at greatest risk for these declines because most are thrust into early menopause from chemotherapy. Hormone manipulation therapy (i.e., tamoxifen or arimidex) may further affect these tissues. Exercise can prevent bone and muscle loss and promote fat loss. However, the ability of exercise to reverse unfavorable changes in all components of body composition in women experiencing early menopause from breast cancer treatment has not been specifically studied.
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
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed breast cancer stage I-IIIa
- Completion of a chemotherapy regimen within the previous 5 years
- Premenopausal status (9-12 menstrual cycles/year) at the initiation of chemotherapy
- Complete absence of menstrual cycles for at least 6 months and within one year after starting chemotherapy OR confirmed menopause by blood tests conducted in the last 12 months prior to enrollment.
Key exclusion criteria (5 listed)
- Presence of any known metastases
- Clinically defined osteoporosis
- Current or previous use of medications known to affect bone metabolism
- Current regular participation (>2x/wk for at least 30 min/session) in planned impact activities (i.e., volleyball, basketball), or resistance training
- A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise
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
Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.
Time frame: 12 months
1 secondary outcome
Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms
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 22996743Winters-Stone KM, Dobek J, Nail LM, Bennett JA, Leo MC, Torgrimson-Ojerio B, Luoh SW, Schwartz A. Impact + resistance training improves bone health and body composition in prematurely menopausal breast cancer survivors: a randomized controlled trial. Osteoporos Int. 2013 May;24(5):1637-46. doi: 10.1007/s00198-012-2143-2. Epub 2012 Sep 21.
- 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 4 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?
Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass. (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 NCT00659906, which also lists 2 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.