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

NCT00194363 | Completed DMC

• 1 other identifier: R01CA106851-01
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphedema

Keywords

breast cancer; breast cancer survivors; lymphedema; strength training; breast cancer survivorship

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• 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.

  1 year

• Secondary aim 2: To assess changes in body composition that may occur from strength training.

  1 year

• 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.

  1 year

• Secondary aim 4: To assess changes in psychosocial mediators of exercise behavior, as well as achievement of outcome expectancies that may occur from participation in strength training.

  1 year

• Secondary aim 5: To assess changes in biomarkers related to breast cancer, among the participants who start the study with a BMI over 25.

  1 year

Interventions

Strength training BEHAVIORAL

13 weeks of supervised strength training (twice weekly for 90 minutes per session), 39 weeks of unsupervised strength training (twice weekly for 90 minutes per session)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• \>10% girth volume difference between the affected and non- affected limb for a non-dominant arm
• % 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.
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Penn State Cancer Institute

Philadelphia, Pennsylvania, 17033, United States

Location

Related Publications (6)

• Zhang 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 DERIVED

• Rogers 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 DERIVED

• Brown 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 DERIVED

• Brown 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 DERIVED

• Schmitz 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 DERIVED

• Schmitz 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 DERIVED

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathryn Schmitz, PhD, MPH

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

US (1)