Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Behavioral: Exercise program

• Registration Number: NCT04449809
• Lead Sponsor: Duke University

Brief Summary

The purpose of this research study is to find out if a monitored group exercise program can increase strength, muscle mass and ability to move in women after treatment for early stage breast cancer.

Detailed Description

This trial will assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements in a group of women treated for early stage breast cancer with the goal of improving functional mobility, body composition, and strength after breast conservation therapy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-21
• Study Start: 2021-09
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 30-70 years
2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
4. BMI > 25 kg/m2 or body fat% greater or equal to 31%
5. Participants must have abstained from smoking for at least 12 months
6. Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment and have undergone a pregnancy test prior to initial of radiation therapy (standard protocol for radiation therapy). They should also consent to use adequate contraception during the course of the study.
7. Women must be determined capable of engaging in resistance training as documented in treating radiation oncologist notes.
8. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
9. Women must complete a Functional Mobility Screen (FMS) and determined safe to engage in the workout regimen by the study personnel.

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Exclusion Criteria

1. Any treatment with chemotherapy for recent breast cancer treatment
2. Mastectomy and/or lymph node dissection
3. Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, and hemoglobin A1c greater than 8.9.
4. Diabetic condition requiring the usage of insulin
5. Severe arthritic, joint, cardiovascular, or musculoskeletal condition
6. Inability to perform body weight squat exercise without pain assessed by treating radiation oncologist
7. History of myocardial infarction or coronary artery disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise program	Exercise program

Primary Outcome Measures

Name	Time	Method
Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions	12 weeks

Trial Locations

Locations (1)

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States