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

NCT01157767 | Completed

• 1 other identifier: 10-062
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

exercise; lymphedema; post-operative chemotherapy; post-operative radiation; 10-062

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

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.

Interventions

standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises. OTHER

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.

breast pts who have undergone surgery

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Heerdt, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: May 11, 2010
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

US (1)