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

Cancer Survivor Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03120390
• Other study ID #: 1B-15-6
• Secondary ID: NCI-2017-005321B
• Status: Withdrawn
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cancer.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Central Obesity
• No Evidence of Disease
• Obesity, Abdominal

Intervention

Other:
• Best Practice
Undergo usual care

Behavioral:
• Exercise Intervention
Undergo AE
• Exercise Intervention
Undergo RE

Other:
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Monitoring Device
Receive Polar heart rate monitor

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MetD	Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.	From week 25 to week 49
Secondary	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.	Baseline to week 49
Secondary	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.	Baseline to week 49
Secondary	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.	Baseline to week 49