Status:
COMPLETED
Strength Training Intervention for Breast Cancer Survivors and the Effects on Lymphedema Status
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors. Study hypothesis: Strength training will not increase the rate of lymphedema or ...
Detailed Description
The proposed study will recruit 288 healthy breast cancer survivors (1-15 years post diagnosis, currently free of cancer), in two strata: 144 BrCa survivors with stable lymphedema (defined in section ...
Eligibility Criteria
Inclusion
- Women without lymphedema must be 1-5 years post breast cancer diagnosis
- Women with lymphedema must be 1-15 years post breast cancer diagnosis
- Women with lymphedema must have stable lymphedema. ONE of the following:
- 0-40\>10% girth volume difference between the affected and non- affected limb for a non-dominant arm
- 6-40% girth volume difference between the affected and non- affected limb for a dominant arm inter-limb discrepancy in volume or circumference at the point of greatest visible difference OR swelling or obscuration of anatomic architecture upon close inspection OR pitting edema.
- 2 cm circumference difference
- A prior clinical diagnosis of lymphedema and having had any prior intensive lymphedema therapy on the affected arm
- As well as ALL of the following four conditions:
- Women with Lymphedema must have ALL of the following:
- No recorded arm girth change of 15% or greater within the three months.
- No more than one lymphedema related infection requiring antibiotics within the past 3 months.
- Participation in all Activities of Daily Living (ADLs) without lymphedema exacerbation for the past 3 months.
Exclusion
- For ALL participants (with and without lymphedema)
- No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- Not morbidly obese (body mass index \>50 kg/m2)
- No plans for additional (e.g. reconstructive) surgery during the study period
- No bilateral breast cancers (because this prohibits our ability to assess the primary outcome of interest)
- No strength training or other upper body resistive exercise within the past year
- Not planning to move away from the area over the next year
- Not pregnant or lactating or planning to become pregnant during the study
- Among women who have given birth: at least 6 months post pregnancy and at least 3 months post lactation
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT00194363
Start Date
October 1 2005
End Date
July 1 2007
Last Update
July 28 2017
Active Locations (1)
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1
Penn State Cancer Institute
Philadelphia, Pennsylvania, United States, 17033