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

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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects may be identified in advance by a member of the patient's treatment team, the principal investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

breast pts who have undergone surgery; 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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Alexandra Heerdt, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2010
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: exercise; lymphedema; post-operative chemotherapy; post-operative radiation; 10-062
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 10-062