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

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ClinicalTrials.gov Identifier: NCT00383500
Recruitment Status : Completed
First Posted : October 3, 2006
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Tracking Information
First Submitted Date  ICMJE September 29, 2006
First Posted Date  ICMJE October 3, 2006
Results First Submitted Date  ICMJE June 6, 2012
Results First Posted Date  ICMJE March 30, 2017
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00383500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
Official Title  ICMJE To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Lymphedema
  • Breast Cancer
Intervention  ICMJE
  • Device: Flexitouch
    A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
    Other Names:
    • Tactile Systems Technology, Inc.
    • Biocompression
    • Lymphatic massage therapy
  • 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
Study Arms  ICMJE
  • Experimental: Flexitouch device
    Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
    Intervention: Device: Flexitouch
  • Experimental: Manual Lymphatic Drainage (MLD)
    Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment
    Intervention: Device: Class 1 compression garment
  • No Intervention: Observational Control (no intervention)
    Control group, no intervention. No Flexitouch or manual massage therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2017)
75
Original Enrollment  ICMJE
 (submitted: October 2, 2006)
200
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383500
Other Study ID Numbers  ICMJE IRB-01671
95970 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0007 ( Other Identifier: OnCore Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided at this time.
Responsible Party Stanley Rockson, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stanley G Rockson Stanford University
PRS Account Stanford University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP