Stage I Breast CancerNCT01140282
Exercise Program for Early Breast Cancer Survivors
A study testing questionnaire administration, quality-of-life assessment and management of therapy complications in people with Stage I Breast Cancer and Stage II Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
Rationale: Exercise therapy may improve the quality of life of breast cancer survivors. Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and management of therapy complications
- Type of treatment
- Surgery or procedure, 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
- 21 May 2012to 1 Oct 2018
- 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
- Newly diagnosed (I-III) with a first primary invasive breast cancer
- Have undergone a lumpectomy or mastectomy
- Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion
- Body mass index (BMI) > 25 kg/m^2 or body fat > 30% (determined by Dr. Dieli-Conwright at baseline visit)
- Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period
- Nonsmokers (i.e., not smoking during previous 12 months)
Show all 9Show fewer
- Willing to travel to the exercise facility and USC
- Able to provide physician clearance to participate in exercise program
- Women of all racial and ethnic backgrounds will be included in the study enrollment process
Who cannot join
- History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
- Weight reduction >= 10% within past 6 months
- Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy)
- Metastatic disease
- Planned reconstructive surgery with flap repair during trial and follow-up period
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
About this study
Official title: Combined Exercise Program for Early Breast Cancer Survivors
Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.
Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
- To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, management of therapy complications, exercise intervention
- Keywords
- cancer survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Administered within 3 days of baseline testing and at post-trial visit
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Administered within 3 days of baseline testing and at post-trial visit
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Assessed within 3 days of baseline testing and at post-trial visit
exercise interventionBehavioural
12 week exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Control) | Active comparator | Patients refrain from increasing physical activity levels for 16 weeks. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications |
| Arm II (Exercise) | Experimental | Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Behavioral: exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c
Measured: At week 16
Improvement of physical fitness, cardiorespiratory fitness, and muscle strength
Measured: At week 16
Feasibility of a supervised exercise program for cancer survivors
Measured: At week 16
Maintain positive benefits of an exercise intervention
Measured: 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study start21 May 2012
- Primary completion28 Sep 2017
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stage I 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Dieli-Conwright, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140282
- Sponsor's protocol ID
- 1B-12-1
- Other IDs
- NCI-2010-01265
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2010
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dieli-Conwright CM, Sami N, Norris MK, Wan J, Kumagai H, Kim SJ, Cohen P. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021 Aug 19;11(1):16916. doi: 10.1038/s41598-021-96419-z.
PubMed 34413391Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Norris MK, Fox FS, Buchanan TA, Spicer D, Bernstein L, Tripathy D. Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis. Sleep. 2021 Oct 11;44(10):zsab111. doi: 10.1093/sleep/zsab111.
PubMed 33929533Lee K, Sami N, Tripathy D, Demark-Wahnefried W, Norris MK, Courneya KS, Dieli-Conwright CM. Aerobic and resistance exercise improves Reynolds risk score in overweight or obese breast cancer survivors. Cardiooncology. 2020 Nov 24;6(1):27. doi: 10.1186/s40959-020-00084-6.
PubMed 33292676Sweeney FC, Demark-Wahnefried W, Courneya KS, Sami N, Lee K, Tripathy D, Yamada K, Buchanan TA, Spicer DV, Bernstein L, Mortimer JE, Dieli-Conwright CM. Aerobic and Resistance Exercise Improves Shoulder Function in Women Who Are Overweight or Obese and Have Breast Cancer: A Randomized Controlled Trial. Phys Ther. 2019 Oct 28;99(10):1334-1345. doi: 10.1093/ptj/pzz096.
PubMed 31309977Lee K, Tripathy D, Demark-Wahnefried W, Courneya KS, Sami N, Bernstein L, Spicer D, Buchanan TA, Mortimer JE, Dieli-Conwright CM. Effect of Aerobic and Resistance Exercise Intervention on Cardiovascular Disease Risk in Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):710-714. doi: 10.1001/jamaoncol.2019.0038.
PubMed 30920602Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.
PubMed 30340503Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Buchanan TA, Spicer DV, Tripathy D, Bernstein L, Mortimer JE. Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Mar 20;36(9):875-883. doi: 10.1200/JCO.2017.75.7526. Epub 2018 Jan 22.
PubMed 29356607Dieli-Conwright CM, Mortimer JE, Schroeder ET, Courneya K, Demark-Wahnefried W, Buchanan TA, Tripathy D, Bernstein L. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods. BMC Cancer. 2014 Apr 3;14:238. doi: 10.1186/1471-2407-14-238.
PubMed 24708832
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Exercise Program for Early Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01140282
- Acronym / sponsor ID
- 1B-12-1
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Keywords
- cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2012 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 9 Jun 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.
Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.
Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
- To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Control) | Active comparator | Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: management of therapy complicationsPatients refrain from increasing physical activity levels for 16 weeks. |
| Arm II (Exercise) | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: management of therapy complications, Behavioral: exercise interventionPatients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed (I-III) with a first primary invasive breast cancer
- Have undergone a lumpectomy or mastectomy
- Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion
- Body mass index (BMI) > 25 kg/m^2 or body fat > 30% (determined by Dr. Dieli-Conwright at baseline visit)
- Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period
Key exclusion criteria (6 listed)
- History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
- Weight reduction >= 10% within past 6 months
- Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy)
- Metastatic disease
- Planned reconstructive surgery with flap repair during trial and follow-up 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 |
|---|---|---|
| questionnaire administrationAdministered within 3 days of baseline testing and at post-trial visit | Other | Arm I (Control), Arm II (Exercise) |
| quality-of-life assessmentAlso: quality of life assessmentAdministered within 3 days of baseline testing and at post-trial visit | Procedure or surgery | Arm I (Control), Arm II (Exercise) |
| management of therapy complicationsAlso: complications of therapy, management ofAssessed within 3 days of baseline testing and at post-trial visit | Procedure or surgery | Arm I (Control), Arm II (Exercise) |
| exercise intervention12 week exercise intervention | Behavioural | Arm II (Exercise) |
Primary outcome
Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c
Time frame: At week 16
Improvement of physical fitness, cardiorespiratory fitness, and muscle strength
Time frame: At week 16
Feasibility of a supervised exercise program for cancer survivors
Time frame: At week 16
Maintain positive benefits of an exercise intervention
Time frame: 12 weeks post-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 18 Jun 2019.
- Derived from this study: PubMed 34413391Dieli-Conwright CM, Sami N, Norris MK, Wan J, Kumagai H, Kim SJ, Cohen P. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021 Aug 19;11(1):16916. doi: 10.1038/s41598-021-96419-z.
- Derived from this study: PubMed 33929533Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Norris MK, Fox FS, Buchanan TA, Spicer D, Bernstein L, Tripathy D. Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis. Sleep. 2021 Oct 11;44(10):zsab111. doi: 10.1093/sleep/zsab111.
- Derived from this study: PubMed 33292676Lee K, Sami N, Tripathy D, Demark-Wahnefried W, Norris MK, Courneya KS, Dieli-Conwright CM. Aerobic and resistance exercise improves Reynolds risk score in overweight or obese breast cancer survivors. Cardiooncology. 2020 Nov 24;6(1):27. doi: 10.1186/s40959-020-00084-6.
- Derived from this study: PubMed 31309977Sweeney FC, Demark-Wahnefried W, Courneya KS, Sami N, Lee K, Tripathy D, Yamada K, Buchanan TA, Spicer DV, Bernstein L, Mortimer JE, Dieli-Conwright CM. Aerobic and Resistance Exercise Improves Shoulder Function in Women Who Are Overweight or Obese and Have Breast Cancer: A Randomized Controlled Trial. Phys Ther. 2019 Oct 28;99(10):1334-1345. doi: 10.1093/ptj/pzz096.
- Derived from this study: PubMed 30920602Lee K, Tripathy D, Demark-Wahnefried W, Courneya KS, Sami N, Bernstein L, Spicer D, Buchanan TA, Mortimer JE, Dieli-Conwright CM. Effect of Aerobic and Resistance Exercise Intervention on Cardiovascular Disease Risk in Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):710-714. doi: 10.1001/jamaoncol.2019.0038.
- Derived from this study: PubMed 30340503Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.
- Derived from this study: PubMed 29356607Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Buchanan TA, Spicer DV, Tripathy D, Bernstein L, Mortimer JE. Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Mar 20;36(9):875-883. doi: 10.1200/JCO.2017.75.7526. Epub 2018 Jan 22.
- Derived from this study: PubMed 24708832Dieli-Conwright CM, Mortimer JE, Schroeder ET, Courneya K, Demark-Wahnefried W, Buchanan TA, Tripathy D, Bernstein L. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods. BMC Cancer. 2014 Apr 3;14:238. doi: 10.1186/1471-2407-14-238.
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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.
Christina Dieli-Conwright, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, quality-of-life assessment and management of therapy complications in people with Stage I Breast Cancer and Stage II Breast Cancer, run by University of Southern California 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 9 inclusion and 6 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 18 Jun 2019. 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?
Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (time frame: At week 16). The study lists 4 primary outcomes in all. 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 NCT01140282, which also lists 8 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 18 Jun 2019; AzTrials last refreshed its copy on 28 Oct 2026.