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
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Breast Cancer||Device: Flexitouch Device: Class 1 compression garment||Not Applicable|
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
- 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
- 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
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Flexitouch device
Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
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).
No Intervention: Observational Control (no intervention)
Control group, no intervention. No Flexitouch or manual massage therapy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383500
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Stanley G Rockson||Stanford University|