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

NCT ID: NCT04449809

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

Exercise program

Group Type: EXPERIMENTAL

Exercise program

Intervention Type: BEHAVIORAL

3x per week group monitored group exercise sessions

Interventions

Exercise program

3x per week group monitored group exercise sessions

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Champ, MD CSCS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00104863

Identifier Type: -

Identifier Source: org_study_id