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

Pilot Study of the Feasibility of an Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Exercise program

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Exercise program	Behavioral: Exercise program; 3x per week group monitored group exercise sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions	12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Colin Champ, MD CSCS, Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: exercise
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00104863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No