Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
Primary Purpose
Breast Cancer, Lymphedema
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Arm, Lymphedema, Breast Cancer, Exercise, Breast Cancer related Lymphedema
Eligibility Criteria
Inclusion Criteria:
- unilateral arm lymphedema as a result of breast cancer treatment
- completion of breast cancer treatments
- arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
- in the maintenance phase of lymphedema treatment
Exclusion Criteria:
- women with recurrent cancer
- intercurrent diseases affecting the swollen arm
- lack of understanding of the Hebrew language
Sites / Locations
- Hillel Yaffe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Muscle Group
Sequence
Arm Description
Exercise
Exercise
Outcomes
Primary Outcome Measures
Improved arm volume measurement
Secondary Outcome Measures
Quality of Life
Full Information
NCT ID
NCT00935714
First Posted
July 8, 2009
Last Updated
August 18, 2009
Sponsor
Hillel Yaffe Medical Center
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT00935714
Brief Title
Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
Collaborators
Tel Aviv University
4. Oversight
5. Study Description
Brief Summary
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema
Keywords
Arm, Lymphedema, Breast Cancer, Exercise, Breast Cancer related Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscle Group
Arm Type
Active Comparator
Arm Description
Exercise
Arm Title
Sequence
Arm Type
Active Comparator
Arm Description
Exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Improved arm volume measurement
Time Frame
Weekly for five weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
Weekly for 5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral arm lymphedema as a result of breast cancer treatment
completion of breast cancer treatments
arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
in the maintenance phase of lymphedema treatment
Exclusion Criteria:
women with recurrent cancer
intercurrent diseases affecting the swollen arm
lack of understanding of the Hebrew language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jillian H Bracha, BSc
Phone
972-523784551
Email
gillianb@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian Bracha, RN
First Name & Middle Initial & Last Name & Degree
Ehud Sternberg, MD
12. IPD Sharing Statement
Learn more about this trial
Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
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