Stanford, California 94305

  • Breast Cancer

Purpose:

To compare the effectiveness of usual treatments for lymphedema (massage and elastic sleeve), instituted even before the development of swelling, compared to the use of a newly marketed device, the Flexitouch®, which electronically simulates the effect of massage upon lymph flow.


Study summary:

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, we propose that physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer will reduce the incidence and degree of lymphatic stagnation when compared to patients who receive conventional 'watch and wait' interventions. 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 our comprehension 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 prototype of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at one woman in four 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. Our 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 is designed to investigate 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.


Criteria:

Inclusion Criteria: 1. Patients referred to the surgeons of the Stanford University Breast Cancer Program 2. Patients will be required to have the capacity to provide informed consent. 3. All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects. 4. All of the subjects to be enrolled in the proposed studies will be patients with unilateral breast cancer who are scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques. Exclusion Criteria: 1. Patients with 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. 2. Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible.


NCT ID:

NCT00383500


Primary Contact:

Principal Investigator
Stanley G Rockson
Stanford University

Les Roche, RN
Phone: (650) 724-5913
Email: lesroche@stanford.edu


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States

Les Roche, RN
Phone: 650-724-5913
Email: lesroche@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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