Cancer SurvivorNCT02235051
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
A study testing exercise intervention, laboratory biomarker analysis and questionnaire administration in people with Cancer Survivor and Estrogen Receptor-positive Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently… Read more about this study
- Who is it for?
- Ages 56 years and older, women only
- Conditions the study is for
- Cancer Survivor, Estrogen Receptor-positive Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- exercise intervention, laboratory biomarker analysis and questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2015to 3 Jun 2022
- 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 56 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatment
- The study will be conducted in postmenopausal women
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Postmenopausal, defined as meeting any of the following criteria:
- Periods stopped more than 6 months ago
- Bilateral oophorectomy
Show all 18Show fewer
- Not already classified as pre- or peri-menopausal
- Started using hormone therapy for menopausal symptoms before periods stopped, and/or
- Hysterectomy before age 56 years but aged 56 years or more at baseline
- Any body mass index (BMI)
- Sedentary (have not participated in a regular exercise program in the past 12 months)
- Nonsmokers (not smoking during previous 12 months)
- Willing and able to travel to the exercise facility
- Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)
- Have undergone a lumpectomy or mastectomy
- Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program
- May use adjuvant endocrine therapy if use will be continued for duration of study period
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
- Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
- Currently taking postmenopausal hormone replacement therapy
- Stage IV or distant metastatic disease
- Planned reconstructive surgery with flap repair during study period
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that regular exercise increases DNA repair capacity.
II. To test the hypothesis that regular exercise reduces inflammatory response.
III. To test the hypothesis that regular exercise modulates telomerase activity.
SECONDARY OBJECTIVES:
- To assess adherence to the study protocol.
II. To examine differences in body composition before and after the exercise intervention.
III. To examine differences in fitness before and after the exercise intervention.
IV. To test the hypothesis that regular exercise increases quality of life in breast cancer survivors.
- To examine the safety of the exercise intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at a Curves facility will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.
ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.
- Conditions
- Cancer Survivor, Estrogen Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- exercise intervention, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Undergo Curves exercise program
laboratory biomarker analysisOther
Correlative studies
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (exercise intervention) | Experimental | Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at Curves will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine. Receives: Behavioral: exercise intervention; Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment |
| Arm II (no formal exercise intervention) | No intervention | Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 60 minutes mean olive tail moments measured by the Comet assay
Comet assay data will be analyzed according to methods by Wiklund et al. Log-transformed, mean Olive tail moments, assessing DNA damage, will be calculated and compared using a paired t-test. For the ex vivo analyses using a challenge assay, Log-transformed, mean Olive tail moments will be calculated before and after the introduction of the damaging agent at 0, 1 and 6 hours. Differences between the changes will be analyzed using the paired t-test. Multivariate analysis of variance (MANOVA) for repeated measure will be performed and linear regression models will be fitted.
Measured: Baseline to 16 weeks
Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Paired t-tests will be used to compare pre-exercise cytokine concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Measured: Baseline to 16 weeks
Change in telomerase activity using the Trypan blue method and ImagedQuant
Paired t-tests will be used to compare pre-exercise telomerase activity in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.
Measured: Baseline to up to 16 weeks
Secondary outcomes (12)
Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay
First, gamma-H2AX foci will be counted, and compared using the paired t-test. Second, for the ex vivo analyses gamma-H2AX foci will be counted before and after the introduction of a damaging agent at 0, 1 and 6 hours. For each time point, a foci change will be obtained. Differences in the foci changes at baseline and 16-weeks will be analyzed using the paired t-test. MANOVA for repeated measures will be performed to allow for the assessment of overall multivariate and univariate results, and linear regression models will be fitted.
Measured: Baseline to 16 weeks
Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Paired t-tests will be used to compare pre-exercise CRP and cytokines concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Measured: Baseline to 16 weeks
Adherence to the study protocol
The CurvesSmart card will record both adherence of going to the sessions and completion of the circuit. Adherence will be analyzed as a continuous variable. During the 16-week testing session, women will be asked what barriers to adherence they may have experienced during the intervention.
Measured: 16 weeks
Changes in weight
A repeated measures analysis of variance (ANOVA) will be used.
Measured: Baseline to 16 weeks
Changes in BMI
A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Changes in percent body fat
A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Changes in cardiopulmonary function
A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Changes in muscle strength
A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Changes in functional capacity
A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Changes in quality of life scores
Changes in quality of life scores will be measured by Cohen's 10-item perceived stress scale, the Fatigue Symptom Inventory, Rosenberg Self-esteem Scale, the Centers for Epidemiology Depression (CESD) Scale, the state trait anxiety index (STAI), the Functional Assessment of Cancer Therapy-Breast scale (FACT-B+4), and Short Form-36 (SF-36) questionnaires. A repeated measures ANOVA will be used.
Measured: Baseline to 16 weeks
Incidence of exercise-attributed injury
During the 16-week testing session, women will be asked details about any injuries or discomfort they may have experienced during the participation in the exercise intervention.
Measured: 16 weeks
Change in telomere length as measured by quantitative polymerase chain reaction
Paired t-tests will be used to compare pre-exercise telomere length in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.
Measured: Baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start12 May 2015
- Primary completion19 Dec 2016
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Clague DeHart, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235051
- Sponsor's protocol ID
- 14135
- Other IDs
- NCI-2014-01876, 14135
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2014
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
- ClinicalTrials.gov ID
- NCT02235051
- Acronym / sponsor ID
- 14135
- Conditions
- Cancer Survivor, Estrogen Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 May 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 9 Sep 2014 (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.
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that regular exercise increases DNA repair capacity.
II. To test the hypothesis that regular exercise reduces inflammatory response.
III. To test the hypothesis that regular exercise modulates telomerase activity.
SECONDARY OBJECTIVES:
- To assess adherence to the study protocol.
II. To examine differences in body composition before and after the exercise intervention.
III. To examine differences in fitness before and after the exercise intervention.
IV. To test the hypothesis that regular exercise increases quality of life in breast cancer survivors.
- To examine the safety of the exercise intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at a Curves facility will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.
ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (exercise intervention) | Experimental | Behavioral: exercise intervention, Other: laboratory biomarker analysis, Other: questionnaire administration, Other: quality-of-life assessmentPatients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at Curves will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine. |
| Arm II (no formal exercise intervention) | No intervention | –Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention. |
Who may qualify
- Ages
- 56 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatment
- The study will be conducted in postmenopausal women
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Postmenopausal, defined as meeting any of the following criteria:
- Any body mass index (BMI)
Key exclusion criteria (7 listed)
- History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
- Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
- Currently taking postmenopausal hormone replacement therapy
- Stage IV or distant metastatic disease
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 |
|---|---|---|
| exercise interventionUndergo Curves exercise program | Behavioural | Arm I (exercise intervention) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (exercise intervention) |
| questionnaire administrationAncillary studies | Other | Arm I (exercise intervention) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (exercise intervention) |
Primary outcome
Change in 60 minutes mean olive tail moments measured by the Comet assay
Time frame: Baseline to 16 weeks
Comet assay data will be analyzed according to methods by Wiklund et al. Log-transformed, mean Olive tail moments, assessing DNA damage, will be calculated and compared using a paired t-test. For the ex vivo analyses using a challenge assay, Log-transformed, mean Olive tail moments will be calculated before and after the introduction of the damaging agent at 0, 1 and 6 hours. Differences between the changes will be analyzed using the paired t-test. Multivariate analysis of variance (MANOVA) for repeated measure will be performed and linear regression models will be fitted.
Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Time frame: Baseline to 16 weeks
Paired t-tests will be used to compare pre-exercise cytokine concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Change in telomerase activity using the Trypan blue method and ImagedQuant
Time frame: Baseline to up to 16 weeks
Paired t-tests will be used to compare pre-exercise telomerase activity in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.
12 secondary outcomes
Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay
Time frame: Baseline to 16 weeks
Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Time frame: Baseline to 16 weeks
Adherence to the study protocol
Time frame: 16 weeks
Changes in weight
Time frame: Baseline to 16 weeks
Changes in BMI
Time frame: Baseline to 16 weeks
Changes in percent body fat
Time frame: Baseline to 16 weeks
Changes in cardiopulmonary function
Time frame: Baseline to 16 weeks
Changes in muscle strength
Time frame: Baseline to 16 weeks
Changes in functional capacity
Time frame: Baseline to 16 weeks
Changes in quality of life scores
Time frame: Baseline to 16 weeks
Incidence of exercise-attributed injury
Time frame: 16 weeks
Change in telomere length as measured by quantitative polymerase chain reaction
Time frame: Baseline up to 16 weeks
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 22 Oct 2026.
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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.
Jessica Clague DeHart principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, laboratory biomarker analysis and questionnaire administration in people with Cancer Survivor and Estrogen Receptor-positive Breast Cancer, run by City of Hope Medical Center 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 18 inclusion and 7 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 22 Oct 2026. 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?
Change in 60 minutes mean olive tail moments measured by the Comet assay (time frame: Baseline to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.