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

Completed

• Conditions: Breast Cancer
• Interventions: Other: standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.

• Registration Number: NCT01157767
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-11
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Status Verified: 2021-08
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast pts who have undergone surgery	standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation.	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.	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States