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

NCT04717050 | Active Not Recruiting DMC

• 1 other identifier: 20-221
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Coronary Artery Disease; Stroke; Type2 Diabetes

Keywords

Breast Cancer; Coronary Artery Disease; Stroke; Type2 Diabetes; Exercise Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance

  16 weeks

• Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity

  16 weeks

• Compare Metabolic Dysregulation (MetD) 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)

  16 weeks

• Metabolic Dysregulation (MetD) Status During 4 month follow up period - Visceral adiposity (VA)

  16 weeks

Study Arms (2)

Progressive combine training (PCT)

EXPERIMENTAL

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)

Attention Control (AC)

ACTIVE COMPARATOR

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)

Interventions

Progressive combine training (PCT) BEHAVIORAL

8 month exercise program with 4 month follow up.

Progressive combine training (PCT)

Attention Control (AC) BEHAVIORAL

12 month stretching program

Attention Control (AC)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Coronary Artery Disease; Stroke

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: August 12, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)