Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors

• ClinicalTrials.gov Identifier: NCT03120390
• Recruitment Status: Withdrawn
• First Posted: April 19, 2017
• Last Update Posted: December 17, 2020
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer Survivor; Central Obesity; No Evidence of Disease	Other: Best Practice; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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)
• Actual Study Start Date: March 8, 2019
• Actual Primary Completion Date: July 31, 2019
• Actual Study Completion Date: July 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group I (PCT); 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.	Behavioral: Exercise Intervention; Undergo AE; Behavioral: Exercise Intervention; Undergo RE; Other: Laboratory Biomarker Analysis; Correlative studies; Device: Monitoring Device; Receive Polar heart rate monitor; Other Name: Monitor; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies
Experimental: Group II (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.	Behavioral: Exercise Intervention; Undergo AE; Other: Laboratory Biomarker Analysis; Correlative studies; Device: Monitoring Device; Receive Polar heart rate monitor; Other Name: Monitor; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies
Active Comparator: 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.	Other: Best Practice; Undergo usual care; Other Names: standard of care; standard therapy; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change in cardiorespiratory fitness [ Time Frame: Baseline to week 49 ]
   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.
2. Change in functional capacity [ Time Frame: Baseline to week 49 ]
   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.
3. Change in muscle strength [ Time Frame: Baseline to week 49 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Christina Dieli-Conwright, Ph.D.; University of Southern California

More Information

• Responsible Party: University of Southern California
• ClinicalTrials.gov Identifier: NCT03120390
• Other Study ID Numbers: 1B-15-6; NCI-2017-00532 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 1B-15-6 ( Other Identifier: USC / Norris Comprehensive Cancer Center ); P30CA014089 ( U.S. NIH Grant/Contract )
• First Posted: April 19, 2017
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Obesity, Abdominal; Obesity; Overnutrition; Nutrition Disorders