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

Breast Cancer Clinical Trial

— EXERT-BC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04449809
• Other study ID #: Pro00104863
• Status: Withdrawn
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: June 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercise program
3x per week group monitored group exercise sessions

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions		12 weeks