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

Primary Purpose

Cancer Survivor, Central Obesity, No Evidence of Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Exercise Intervention
Exercise Intervention
Laboratory Biomarker Analysis
Monitoring Device
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group I (PCT)

Group II (PAT)

Group III (usual care)

Arm Description

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.

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.

Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I.

Outcomes

Primary Outcome Measures

Change in MetD
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 13, 2017
Last Updated
December 15, 2020
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03120390
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Central Obesity, No Evidence of Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (PCT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (PAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group III (usual care)
Arm Type
Active Comparator
Arm Description
Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Undergo usual care
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo AE
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo RE
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Device
Intervention Name(s)
Monitoring Device
Other Intervention Name(s)
Monitor
Intervention Description
Receive Polar heart rate monitor
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in MetD
Description
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.
Time Frame
From week 25 to week 49
Secondary Outcome Measure Information:
Title
Change in cardiorespiratory fitness
Description
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.
Time Frame
Baseline to week 49
Title
Change in functional capacity
Description
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.
Time Frame
Baseline to week 49
Title
Change in muscle strength
Description
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.
Time Frame
Baseline to week 49

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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