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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00383500
• Other study ID #: BRSNSTU0007
• Secondary ID: 95970
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2006
• Last updated: October 25, 2011
• Start date: May 2005
• Est. completion date: May 2015

Study information

• Verified date: October 2011
• Source: Stanford University
• Contact: Les Roche, RN
• Phone: (650) 724-5913
• Email: lesroche[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Flexitouch
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New development of lymphedema by bioimpedance spectroscopy		36 months	No
Primary	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		3 years of semi-annual follow-up	No
Secondary	new increases in limb volume		36 months	No
Secondary	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 years	No
Secondary	To correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume		3 years	No