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

NCT04449809 | Withdrawn

• 1 other identifier: Pro00104863
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

• Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions

  12 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Exercise program

Behavioral: Exercise program

Interventions

Exercise program BEHAVIORAL

3x per week group monitored group exercise sessions

Exercise

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-70 years
• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
• Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
• BMI \> 25 kg/m2 or body fat% greater or equal to 31%
• Participants must have abstained from smoking for at least 12 months
• 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.
• Women must be determined capable of engaging in resistance training as documented in treating radiation oncologist notes.
• Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
• Women must complete a Functional Mobility Screen (FMS) and determined safe to engage in the workout regimen by the study personnel.

You may not qualify if:

• Any treatment with chemotherapy for recent breast cancer treatment
• Mastectomy and/or lymph node dissection
• Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, and hemoglobin A1c greater than 8.9.
• Diabetic condition requiring the usage of insulin
• Severe arthritic, joint, cardiovascular, or musculoskeletal condition
• Inability to perform body weight squat exercise without pain assessed by treating radiation oncologist
• History of myocardial infarction or coronary artery disease

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Colin Champ, MD CSCS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)