Clinical trial · Interventional
Strength Training Intervention for Breast Cancer Survivors and the Effects on Lymphedema Status
The PAL Trial (Physical Activity and Lymphedema)
NCT00194363CI-TRIAL-00028814completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Strength training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group.
- timeFrame
- 1 year
Secondary outcomes (5)
- measure
- Secondary aim 1: To assess changes in physical functioning of the arms, as measured by tests of range of motion, coordination, pain, and strength that may result from strength training.
- timeFrame
- 1 year
- measure
- Secondary aim 2: To assess changes in body composition that may occur from strength training.
- timeFrame
- 1 year
- measure
- Secondary aim 3: To assess self-reported changes in health related quality of life, sleep, fatigue, self-esteem, optimism, life satisfaction, sexual function, body image, social support, and general quality of life.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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 Criteria:
* 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 lactationReferences
Publications (6)
- DERIVEDZhang X, Brown JC, Paskett ED, Zemel BS, Cheville AL, Schmitz KH. Changes in arm tissue composition with slowly progressive weight-lifting among women with breast cancer-related lymphedema. Breast Cancer Res Treat. 2017 Jul;164(1):79-88. doi: 10.1007/s10549-017-4221-9. Epub 2017 Apr 8. PMID 28391397
- DERIVEDRogers BH, Brown JC, Gater DR, Schmitz KH. Association Between Maximal Bench Press Strength and Isometric Handgrip Strength Among Breast Cancer Survivors. Arch Phys Med Rehabil. 2017 Feb;98(2):264-269. doi: 10.1016/j.apmr.2016.07.017. Epub 2016 Aug 16. PMID 27543047
- DERIVEDBrown JC, Schmitz KH. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Oncol. 2015 Jul 1;33(19):2184-9. doi: 10.1200/JCO.2014.57.7395. Epub 2015 May 11. PMID 25964257
- DERIVEDBrown JC, Troxel AB, Schmitz KH. Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Oncologist. 2012;17(8):1120-8. doi: 10.1634/theoncologist.2012-0035. Epub 2012 Jul 2. PMID 22752068
- DERIVEDSchmitz KH, Ahmed RL, Troxel AB, Cheville A, Lewis-Grant L, Smith R, Bryan CJ, Williams-Smith CT, Chittams J. Weight lifting for women at risk for breast cancer-related lymphedema: a randomized trial. JAMA. 2010 Dec 22;304(24):2699-705. doi: 10.1001/jama.2010.1837. Epub 2010 Dec 8. PMID 21148134
- DERIVEDSchmitz KH, Ahmed RL, Troxel A, Cheville A, Smith R, Lewis-Grant L, Bryan CJ, Williams-Smith CT, Greene QP. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009 Aug 13;361(7):664-73. doi: 10.1056/NEJMoa0810118. PMID 19675330