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

• 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: Stanford University
• Information provided by (Responsible Party): Stanley Rockson, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lymphedema; Breast Cancer	Device: Flexitouch; Device: Class 1 compression garment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• 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
• Study Start Date: May 2005
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: IRB-01671; 95970 ( Other Identifier: Stanford University Alternate IRB Approval Number ); BRSNSTU0007 ( Other Identifier: OnCore Number )
• First Posted: October 3, 2006
• 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