Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment standardized regimen of exercises, including a warm-up period, rom arm exercises, and strength training exercises.
Sponsor Memorial Sloan Kettering Cancer Center
Start date May 2010
End date May 2017
Trial size 90 participants
Trial identifier NCT01157767, 10-062

Summary

The purpose of this study is to study if a patients follows an exercise program specifically designed for them during the time of their treatment after surgery. Their ability to follow the program and its influence on their weight maintenance and early post-operative lymphedema rates will also be studied. Lymphedema is a condition in which excess fluid collects in tissue and causes swelling of the arm(s).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
This will be a feasibility study designed to evaluate the compliance of an at-home, directed exercise program and its influence on physical measures during post-operative adjuvant chemotherapy and radiation (if applicable).
standardized regimen of exercises, including a warm-up period, rom arm exercises, and strength training exercises.
Module I is a group of arm movements. It consists of stretching exercises coordinated with breathing exercises to restore their physical mobility, range of motion and flexibility of shoulders. Module I is to be performed daily. In Module II the exercises are a series of copyrighted, sequential movements designed to put the body in proper alignment. It is a special series of muscle movements to help establish better body alignment, as well as increased strength and flexibility of one's arms, legs, and spine, each exercise is 4 repetitions. Module III is the walking and the resistance weight training program. The walking program is whole body exercise, multi-joint, weight-bearing, low impact and for beginners to advanced.

Primary Outcomes

Measure
To evaluate compliance with and demonstrate the feasibility of an at-home, directed exercise program during adjuvant chemotherapy and radiation (if applicable).
time frame: 2 years

Secondary Outcomes

Measure
To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation.
time frame: 2 years
To describe how this exercise program affects early post-operative lymphedema rates, monitoring the strength training specifics -including the number of repetitions and sets of each exercise, frequency, and order of exercises.
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patients will be eligible if they have any of the following surgical procedures performed by an attending on the Breast Service: SLNB alone Axillary lymph node dissection (ALND) alone Total Mastectomy TM (+/- reconstruction) with SLNB or ALND Breast conserving therapy (BCT) with SLNB or ALND - Age > 18 years - Planned to undergo adjuvant post-operative chemotherapy with or without radiation at MSKCC and have not yet started chemotherapy Exclusion Criteria: - Undergoing TM or BCT without SLNB - Having had prior breast cancer treated with surgery - Unable to participate in a exercise program related to other medical problems - More than 8 weeks post surgery. - Having a concurrent cancer in addition to breast cancer - Who have had any type of chemotherapy in the past two years

Additional Information

Official title A Feasibility Study of the Effects of a Directed Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation
Principal investigator Alexandra Heerdt, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.