Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

NCT00383500 | Completed Results DMC

• 3 other identifiers: IRB-0167195970BRSNSTU0007
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of usual treatments for lymphedema \[massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)\], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.

Conditions

Lymphedema; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy

  Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups

  36 months

• Incidence of Lymphedema (Newly-developing)

  Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.

  3 years of semi-annual follow-up

Study Arms (3)

Flexitouch device

EXPERIMENTAL

Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)

Device: Flexitouch

Manual Lymphatic Drainage (MLD)

EXPERIMENTAL

Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment

Device: Class 1 compression garment

Observational Control (no intervention)

NO INTERVENTION

Control group, no intervention. No Flexitouch or manual massage therapy

Interventions

Flexitouch DEVICE

A standard of care intermittent pneumatic compression device (aka, lymphedema pump)

Also known as: Tactile Systems Technology, Inc., Biocompression, Lymphatic massage therapy

Flexitouch device

Class 1 compression garment DEVICE

Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).

Also known as: Manual lymphatic drainage, Lymphatic massage therapy

Manual Lymphatic Drainage (MLD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral breast cancer
• Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.
• Referred to the surgeons of the Stanford University Breast Cancer Program
• Capacity to provide informed consent.
• All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.

You may not qualify if:

• Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
• Recurrent breast cancer or other forms of pre-existing lymphedema.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Manual Lymphatic Drainage

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)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Stanley G. Rockson
• Organization: Stanford University

rockson@stanford.edu

650-725-7571

Study Officials

• Stanley G Rockson

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Lymphatic Research and Medicine

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: May 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Locations

US (1)