Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)

Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment

Control group, no intervention. No Flexitouch or manual massage therapy

A standard of care intermittent pneumatic compression device (aka, lymphedema pump)

Flexitouch

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).

Class 1 compression garment

Stanley G Rockson

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.

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.

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

To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups

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.

Stanford University

Professor of Lymphatic Research and Medicine

Flexitouch Device

Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.

Manual Lymphatic Drainage (MLD)

Observational Control (no Intervention)

This group of patients will receive the device.

Group I

This group of patients will receive prophylactic MLD

Group II

This is the control group; they will receive no treatment

Group III

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Stanley G. Rockson

Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)

Lymphedema management via self-administered manual lymphatic drainage therapy

No Intervention Control

All enrolled patients in the trial who did not withdraw or were lost to follow-up

Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy

Lymphedema management via self-administered manual lymphatic massage therapy

Spots Global Cancer Trial Database for class 1 compression garment