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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01157767
First received: July 6, 2010
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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).


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study of the Effects of a Directed Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: May 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157767

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Alexandra Heerdt, MD, MPH Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01157767     History of Changes
Other Study ID Numbers: 10-062
Study First Received: July 6, 2010
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
exercise
lymphedema
post-operative chemotherapy
post-operative radiation
10-062

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014