Clinical trial NCT04449809: Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: exercise
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Colin Champ, MD CSCS
role: PRINCIPAL_INVESTIGATOR
References: