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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, 2013
Last verified: April 2013
History of Changes

July 6, 2010
April 24, 2013
May 2010
May 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01157767 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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).
Breast Cancer
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.
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).
Intervention: Other: standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01157767
10-062
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Alexandra Heerdt, MD, MPH Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP