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

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Stroke; Breast Cancer; Type2 Diabetes
• Intervention / Treatment: Behavioral: Progressive combine training (PCT); Behavioral: Attention Control (AC)

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:

  1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
  2. 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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Norris, MS; Phone Number: 857-215-0195; Email: maryk_norris@dfci.harvard.edu
• Study Contact Backup: Name: Christina Dieli-Conwright, PhD, MPH; Phone Number: 617-582-8321; Email: ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Principal Investigator: Christina Dieli-Conwright, PhD
      • Contact: Mary Norris, MS; Phone Number: 857-215-0195; Email: maryk_norris@dfci.harvard.edu
      • Contact: Christina Dieli-Conwright, PhD, MPH; Phone Number: 617-582-8321; Email: ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance	Changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA)	16 weeks
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity	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)	16 weeks
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY)	Frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance	Compare changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) in Progressive Combine Training (PCT) and Attention (AC) groups	16 weeks
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity	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	16 weeks
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)	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)	16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - insulin resistance (IR)	Change in insulin resistance (IR) status from end of study PCT to 4 month follow up measured by Homeostasis Model Assessment (HOMA).	16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - Visceral adiposity (VA)	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).	16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - metabolic syndrome (MSY)	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)	16 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Christina Dieli-Conwright, PhD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Stroke; Coronary Artery Disease; Exercise Therapy; Type2 Diabetes
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Diabetes Mellitus; Breast Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus, Type 2; Breast Neoplasms
• Other Study ID Numbers: 20-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No