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

Not Applicable

Completed

Conditions: Lymphedema
Breast Cancer

Interventions: Device: Flexitouch
Device: Class 1 compression garment

Registration Number: NCT00383500

Lead Sponsor: Stanford University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 75

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexitouch device	Flexitouch	Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
Manual Lymphatic Drainage (MLD)	Class 1 compression garment	Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy	36 months	Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Incidence of Lymphedema (Newly-developing)	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.

Secondary Outcome Measures