Strength Training Intervention for Breast Cancer Survivors and the Effects on Lymphedema Status

Completed · Not applicable

Conditions studied: Lymphedema

In brief

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 worsen lymphedema as compared to the non-exercising control participants.

Key facts

Study ID

NCT00194363

Run by

Milton S. Hershey Medical Center

People needed

295

Starts

2005-10-01

Expected to finish

2007-07-01

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Penn State Cancer Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.