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

18 Years
Open (Enrolling)
Lymphedema, Breast Cancer

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

New development of lymphedema by bioimpedance spectroscopy

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Stanley G Rockson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

May 2015

Related Keywords:

  • Lymphedema
  • Breast Cancer
  • Breast Neoplasms
  • Lymphedema



Stanford University School of Medicine Stanford, California  94305-5317