Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04717050

Collaborator

American Cancer Society, Inc. (Other)

160

Enrollment

Location

Arms

58.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Coronary Artery Disease Stroke Type2 Diabetes	Behavioral: Progressive combine training (PCT) Behavioral: Attention Control (AC)	N/A

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants in this study will be randomly assigned into one of the study groups:

Progressive Combine Training (PCT) or Attention Control.

Progressive combined training (PCT) will be performed in 2 phases:

supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.

Attention Control Group: 51 weeks home-based stretching

All participants will undergo seven blood draws and participate in nine testing visits.

Participation is expected to last 12 months for all participants.

It is expected that about 160 people will take part in this research study.

The American Cancer Society is supporting this research study by providing funding for the research study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 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

Actual Study Start Date :

Aug 12, 2021

Anticipated Primary Completion Date :

Jun 15, 2025

Anticipated Study Completion Date :

Jun 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Progressive combine training (PCT) Participants will be randomly assigned to Progressive combine training (PCT) group. Participants will have two (2) baseline tests, then begin a two phase PCT program. Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom Participants will receive midpoint testing, approximately week 8. Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home Participants will receive midpoint testing, approximately two months into phase 2. After the two (2) 16-week phases, participants will be followed for 4 months.	Behavioral: Progressive combine training (PCT) 8 month exercise program with 4 month follow up.
Active Comparator: Attention Control (AC) Participants will be randomly assigned to Attention Control (AC) group. Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12.	Behavioral: Attention Control (AC) 12 month stretching program

Arm

Intervention/Treatment

Experimental: Progressive combine training (PCT)

Participants will be randomly assigned to Progressive combine training (PCT) group. Participants will have two (2) baseline tests, then begin a two phase PCT program. Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom Participants will receive midpoint testing, approximately week 8. Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home Participants will receive midpoint testing, approximately two months into phase 2. After the two (2) 16-week phases, participants will be followed for 4 months.

Behavioral: Progressive combine training (PCT)

8 month exercise program with 4 month follow up.

Active Comparator: Attention Control (AC)

Participants will be randomly assigned to Attention Control (AC) group. Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12.

Behavioral: Attention Control (AC)

12 month stretching program

Outcome Measures

Primary Outcome Measures

Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance [16 weeks]
Changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA)
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity [16 weeks]
Changes from baseline in visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA)
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY) [16 weeks]
Frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA)

Secondary Outcome Measures

Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance [16 weeks]
Compare changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) in Progressive Combine Training (PCT) and Attention (AC) groups
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity [16 weeks]
Compare changes from baseline in Visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA) in Progressive Combine Training (PCT) and Attention (AC) groups
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY) [16 weeks]
Compare frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)
Metabolic Dysregulation (MetD) Status During 4 month follow up period - insulin resistance (IR) [16 weeks]
Change in insulin resistance (IR) status from end of study PCT to 4 month follow up measured by Homeostasis Model Assessment (HOMA).
Metabolic Dysregulation (MetD) Status During 4 month follow up period - Visceral adiposity (VA) [16 weeks]
Change in Visceral adiposity (VA) status from end of study PCT to 4 month follow up measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA).
Metabolic Dysregulation (MetD) Status During 4 month follow up period - metabolic syndrome (MSY) [16 weeks]
Change in metabolic syndrome (MSY) frequency from end of study PCT to 4 month follow up diagnosed by criteria accepted by the American Heart Association (AHA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women newly diagnosed (Stage I-III) breast cancer.
Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
Are centrally obese with the following criteria[84] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
Have undergone a lumpectomy or mastectomy.
Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
Speak English or Spanish
Self-identify as Latina
Is in breast cancer remission with no detectable disease present
Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
Have not experienced a weight reduction ≥10% within the past 6 months
Currently participate in less than 60 minutes of structured exercise/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 intervention
Does not smoke (no smoking during previous 12 months)
Willing to travel to Dana-Farber Cancer Institute for necessary data collection
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Patients with other active malignancies are ineligible for this study.
Patients with metastatic disease
Is not centrally obese as defined above
Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
Participates in more than 60 minutes of structured exercise/week
Is planning reconstructive surgery with flap repair during trial and follow-up period
Currently smokes
Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
Weight reduction ≥ 10% within past 6 months
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.