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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383500
First Posted: October 3, 2006
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
  Purpose
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.

Condition Intervention
Lymphedema Breast Cancer Device: Flexitouch Device: Class 1 compression garment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

Resource links provided by NLM:


Further study details as provided by Stanley Rockson, Stanford University:

Primary Outcome Measures:
  • Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy [ Time Frame: 36 months ]
    Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups

  • Incidence of Lymphedema (Newly-developing) [ Time Frame: 3 years of semi-annual follow-up ]
    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.


Enrollment: 75
Study Start Date: May 2005
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flexitouch device
Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
Device: Flexitouch
A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
Other Names:
  • Tactile Systems Technology, Inc.
  • Biocompression
  • Lymphatic massage therapy
Experimental: Manual Lymphatic Drainage (MLD)
Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment
Device: Class 1 compression garment
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).
Other Names:
  • Manual lymphatic drainage
  • Lymphatic massage therapy
No Intervention: Observational Control (no intervention)
Control group, no intervention. No Flexitouch or manual massage therapy

Detailed Description:

The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).

The specific aims of the study are

  1. to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
  2. to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
  3. to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume

Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383500


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley G Rockson Stanford University
  More Information

Responsible Party: Stanley Rockson, Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00383500     History of Changes
Other Study ID Numbers: IRB-01671
95970 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0007 ( Other Identifier: OnCore Number )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Results First Submitted: June 6, 2012
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided at this time.

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases