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Exercise for Breast Cancer Survivors

N/A

Recruiting

Led By Christina Dieli-Conwright, PhD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Women newly diagnosed (Stage I-III) breast cancer

Must not have

Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis

Unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether exercise can help Latina breast cancer survivors by improving fitness and reducing risks for heart disease, diabetes, and obesity.

Who is the study for?

This trial is for Latina breast cancer survivors who are obese, have completed their main cancer treatments within the last year, and currently exercise less than 60 minutes a week. They must not smoke, be free from serious chronic diseases, agree to use contraception if applicable, and be willing to travel for the study.

What is being tested?

The study tests whether Progressive Combined Training (PCT), an exercise program, can improve fitness and reduce heart disease, diabetes, and obesity risks compared to standard care (Attention Control) in participants.

What are the potential side effects?

While specific side effects aren't listed for this type of physical activity intervention, typical concerns might include muscle soreness or strain. The trial will monitor for any adverse reactions related to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use effective birth control or abstain from sex for six months during the study.

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I am a woman with newly diagnosed Stage I-III breast cancer.

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I am over 18 years old.

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My breast cancer is in remission with no signs of disease.

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I have had surgery to remove a breast lump or the entire breast.

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I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.

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I can start an exercise program without heart, lung, or joint issues stopping me.

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I am obese with a BMI over 30, body fat over 30%, and waist size over 35 inches.

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I have not lost more than 10% of my weight in the last 6 months.

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I do not plan to have reconstructive surgery with flap repair during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't finished any surgery, chemotherapy, or radiation for my diagnosis.

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I cannot travel to the specified hospital or exercise facility for data collection.

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I do not have any uncontrolled illnesses or infections, and if I'm a woman with diabetes, I'm not using Metformin.

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My cancer has spread to other parts of my body.

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I plan to have reconstructive surgery with flap repair during the study.

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I am not currently on any experimental treatments or undergoing chemotherapy or radiation.

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I don't have any muscle, heart, lung, or nerve conditions that stop me from exercising.

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I do not have any other active cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance

Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity

Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY)

Secondary study objectives

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

Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Progressive combine training (PCT)Experimental Treatment1 Intervention

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.

Group II: Attention Control (AC)Active Control1 Intervention

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.

0 / 18Eligibility criteria met