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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00383500
First received: September 29, 2006
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

To compare the effectiveness of usual treatments for lymphedema (massage and elastic sleeve), instituted even before the development of swelling, 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Stanford University:

Primary Outcome Measures:
  • New development of lymphedema by bioimpedance spectroscopy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 years of semi-annual follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • new increases in limb volume [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Flexitouch
    Standard of Care
    Other Names:
    • Tactile Systems Technology, Inc.
    • biocompression
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, we propose that physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer will reduce the incidence and degree of lymphatic stagnation when compared to patients who receive conventional 'watch and wait' interventions.

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 our comprehension 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 prototype of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at one woman in four 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. Our 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 is designed to investigate 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients referred to the surgeons of the Stanford University Breast Cancer Program
  2. Patients will be required to have the capacity to provide informed consent.
  3. All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.
  4. All of the subjects to be enrolled in the proposed studies will be patients with unilateral breast cancer who are scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.

Exclusion Criteria:

  1. Patients with 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.
  2. Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383500

Contacts
Contact: Les Roche, RN (650) 724-5913 lesroche@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Les Roche, RN    650-724-5913    lesroche@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Stanley G Rockson         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley G Rockson Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00383500     History of Changes
Other Study ID Numbers: BRSNSTU0007, 95970
Study First Received: September 29, 2006
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014