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Exercise for Breast Cancer

N/A

Recruiting

Led By Christina M Dieli-Conwright, PhD

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

Have undergone a lumpectomy or mastectomy

Is in breast cancer remission with no detectable disease present

Must not have

Patients with other active malignancies are ineligible for this study

Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Summary

This trial will test whether exercising can help breast cancer patients by decreasing inflammation in their fat tissue.

Who is the study for?

This trial is for women over 18 with breast cancer who've finished treatment, are in remission, and meet specific health criteria like a BMI >30. They must not have other uncontrolled illnesses or be on certain treatments. Participants should exercise less than 60 minutes per week and agree to use contraception.

What is being tested?

The study tests if a 16-week exercise program can reduce inflammation in fat tissue of breast cancer survivors. It involves TARE (Targeted Radiotherapy), Home-Based Stretching, and CARE (Comprehensive Assessment and Response Evaluation).

What are the potential side effects?

While the trial focuses on exercise, potential side effects may include typical risks associated with physical activity such as muscle soreness, fatigue, or injury especially if participants have pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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

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I can start a supervised exercise program without health issues stopping me.

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I have breast cancer that is not stage IV, is low grade, and positive for estrogen and progesterone.

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I am over 18 years old.

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

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

Exclusion Criteria

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

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I do not have any other active cancers.

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I do not have any uncontrolled illnesses like infections or diabetes.

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

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My cancer has spread to other parts of my body.

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I do not have any muscle, heart, lung, or nerve conditions that prevent me from exercising.

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I cannot travel to the exercise facilities.

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

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

Decrease in adipose tissue levels of inflammation.

Secondary study objectives

Interventional procedure

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Traditional Aerobic Resistance Exercise (TARE)Experimental Treatment1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months - 16 weeks of traditional aerobic and resistance exercise

Group II: Circuit-style aerobic and resistance Exercise(CARE)Experimental Treatment1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months. -16 weeks of circuit-style aerobic and resistance exercise

Group III: Home-Based StretchingActive Control1 Intervention

Attention Control for 16 weeks home-based stretching -structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,100 Previous Clinical Trials

352,797 Total Patients Enrolled

144 Trials studying Breast Cancer

21,712 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,700 Total Patients Enrolled

944 Trials studying Breast Cancer

1,543,664 Patients Enrolled for Breast Cancer

Christina M Dieli-Conwright, PhDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

CARE Clinical Trial Eligibility Overview. Trial Name: NCT04720209 — N/A

Breast Cancer Research Study Groups: Home-Based Stretching, Traditional Aerobic Resistance Exercise (TARE), Circuit-style aerobic and resistance Exercise(CARE)

Breast Cancer Clinical Trial 2023: CARE Highlights & Side Effects. Trial Name: NCT04720209 — N/A

CARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04720209 — N/A

~52 spots leftby Jun 2025

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