Clinical trial NCT03120390: Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer Survivor
Central Obesity
No Evidence of Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 cancer.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in MetD
timeFrame: From week 25 to week 49
Secondary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline to week 49
measure: Change in functional capacity
timeFrame: Baseline to week 49
measure: Change in muscle strength
timeFrame: Baseline to week 49
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Christina Dieli-Conwright, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: