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

June 15, 2021 updated by: Duke University

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Withdrawn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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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