Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation

Breast Cancer Clinical Trial

Official title:

A Feasibility Study of the Effects of a Directed Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157767
• Other study ID #: 10-062
• Status: Completed
• Start date: May 11, 2010
• Est. completion date: August 23, 2021

Study information

• Verified date: August 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate compliance with and demonstrate the feasibility of an at-home, directed exercise program during adjuvant chemotherapy and radiation (if applicable).		2 years
Secondary	To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation.		2 years
Secondary	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.		2 years

External Links

•   Memorial Sloan Kettering Cancer Center