Cancer SurvivorNCT03120390
Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors
A study testing Best Practice, Exercise Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Central Obesity, run by University of Southern California at 1 site in United States.
Trial summary
This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Survivor, Central Obesity, No Evidence of Disease
- What is being tested?
- Best Practice, Exercise Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 31 Jul 2019
- 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 (stage I-III) breast cancer
- Self-identify as Latina
- Have undergone a lumpectomy or mastectomy
- Have received and completed neoadjuvant or adjuvant cytotoxic chemotherapy and/or radiation therapy within the past 12 months
- Have no evidence of cancer disease after treatment (confirmed by their treating physician)
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; obtains clearance from physician to confirm status)
Show all 14Show fewer
- Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 30 kg/m^2 (calculated using height and weight) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 inches (in)
- Free from history of chronic disease including severe diabetes (glycosylated hemoglobin [HgA1c] > 7% requiring a pharmacologic intervention), uncontrolled hypertension or thyroid disease (obtains clearance from physician to confirm status)
- Have not experienced a weight reduction >= 10% within past 6 months; and body weight has remained stable for the past 4 weeks
- Currently participate in less than 60 minutes of physical activity/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy if use will be continued for duration of study period
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided)
Who cannot join
- Currently pregnant
- History of chronic disease including uncontrolled diabetes, uncontrolled hypertension or uncontrolled thyroid disease; women using metformin to manage diabetes will be excluded from the trial
- Weight reduction >= 10% within past 6 months
- 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, 90033
About this study
Official title: Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)
This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effects of a 6-month progressive combined training (PCT) program on metabolic dysregulation (MetD) in centrally obese latina breast cancer survivors (LBCS).
SECONDARY OBJECTIVES:
- To determine whether improved physical fitness and health-related measures from a 6-month PCT program are associated with reductions in MetD in centrally obese LBCS.
II. To determine whether MetD status and physical fitness can be maintained following a 6-month follow-up period and to establish predictors of exercise behavior in LBCS.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I (PROGRESSIVE COMBINED TRAINING [PCT]): Patients undergo supervised exercise sessions comprising of aerobic exercise (AE) over 30 minutes and resistance exercise (RE) over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
GROUP II (PROGRESSIVE AEROBIC TRAINING [PAT]): Patients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
GROUP III (USUAL CARE): Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I.
After completion of study, patients are followed up at 37 and 49 weeks.
- Conditions
- Cancer Survivor, Central Obesity, No Evidence of Disease
- Being tested
- Best Practice, Exercise Intervention, Laboratory Biomarker Analysis, Monitoring Device, Quality-of-Life Assessment
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo usual care
Exercise InterventionBehavioural
Undergo AE
Exercise InterventionBehavioural
Undergo RE
Laboratory Biomarker AnalysisOther
Correlative studies
Monitoring DeviceDevice
Also called Monitor
Receive Polar heart rate monitor
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (PCT) | Experimental | Patients undergo supervised exercise sessions comprising of AE over 30 minutes and RE over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (PAT) | Experimental | Patients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group III (usual care) | Active comparator | Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I. Receives: Other: Best Practice; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MetD
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.
Measured: From week 25 to week 49
Secondary outcomes (3)
Change in cardiorespiratory fitness
Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
Measured: Baseline to week 49
Change in functional capacity
1). Hand grip strength: Grip strength will be measured using a hand-held dynamometer on the participant's dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure as possible while holding for 2 seconds; 2). Y Balance Test: All subjects will be required to complete the Y Balance by standing on a single limb and reach as far as possible with the opposite limb; 3). Modified Margaria-Kalamen Step Test will be used to test leg muscle power. Subjects will climb a flight of 10 stairs as quickly as possible, without missing a stair and will be evaluated based on time-to-completion and accuracy of completing all steps, given a total of 3 chances to complete the test as quickly as possible.
Measured: Baseline to week 49
Change in muscle strength
The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
Measured: Baseline to week 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start8 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: PI left institution
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 University of Southern CaliforniaThe 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
- None (open label)
- Enrolment
- 0 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
- NCT03120390
- Sponsor's protocol ID
- 1B-15-6
- Other IDs
- NCI-2017-00532, 1B-15-6, P30CA014089
- Status last verified
- Dec 2020
- First submitted
- 13 Apr 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)
- ClinicalTrials.gov ID
- NCT03120390
- Acronym / sponsor ID
- 1B-15-6
- Conditions
- Cancer Survivor, Central Obesity, No Evidence of Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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 phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effects of a 6-month progressive combined training (PCT) program on metabolic dysregulation (MetD) in centrally obese latina breast cancer survivors (LBCS).
SECONDARY OBJECTIVES:
- To determine whether improved physical fitness and health-related measures from a 6-month PCT program are associated with reductions in MetD in centrally obese LBCS.
II. To determine whether MetD status and physical fitness can be maintained following a 6-month follow-up period and to establish predictors of exercise behavior in LBCS.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I (PROGRESSIVE COMBINED TRAINING [PCT]): Patients undergo supervised exercise sessions comprising of aerobic exercise (AE) over 30 minutes and resistance exercise (RE) over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
GROUP II (PROGRESSIVE AEROBIC TRAINING [PAT]): Patients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions.
GROUP III (USUAL CARE): Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I.
After completion of study, patients are followed up at 37 and 49 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (PCT) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Device: Monitoring Device, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo supervised exercise sessions comprising of AE over 30 minutes and RE over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. |
| Group II (PAT) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Device: Monitoring Device, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. |
| Group III (usual care) | Active comparator | Other: Best Practice, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Newly diagnosed (stage I-III) breast cancer
- Self-identify as Latina
- Have undergone a lumpectomy or mastectomy
- Have received and completed neoadjuvant or adjuvant cytotoxic chemotherapy and/or radiation therapy within the past 12 months
- Have no evidence of cancer disease after treatment (confirmed by their treating physician)
Key exclusion criteria (6 listed)
- Currently pregnant
- History of chronic disease including uncontrolled diabetes, uncontrolled hypertension or uncontrolled thyroid disease; women using metformin to manage diabetes will be excluded from the trial
- Weight reduction >= 10% within past 6 months
- 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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo usual care | Other | Group III (usual care) |
| Exercise InterventionUndergo AE | Behavioural | Group I (PCT), Group II (PAT) |
| Exercise InterventionUndergo RE | Behavioural | Group I (PCT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (PCT), Group II (PAT), Group III (usual care) |
| Monitoring DeviceAlso: MonitorReceive Polar heart rate monitor | Device | Group I (PCT), Group II (PAT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (PCT), Group II (PAT), Group III (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (PCT), Group II (PAT), Group III (usual care) |
Primary outcome
Change in MetD
Time frame: From week 25 to week 49
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.
3 secondary outcomes
Change in cardiorespiratory fitness
Time frame: Baseline to week 49
Change in functional capacity
Time frame: Baseline to week 49
Change in muscle strength
Time frame: Baseline to week 49
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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 Best Practice, Exercise Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Central Obesity, 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 14 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: withdrawn, as of the sponsor's last update on 17 Dec 2020. 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 was withdrawn before enrolling participants, so there are no results.
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 MetD (time frame: From week 25 to week 49). 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 17 Dec 2020.