The Use of Selenium to Treat Secondary Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-01-31

Brief Summary

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The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.

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Detailed Description

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Conditions

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Breast Neoplasms Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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sodium selenite

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
* patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
* ECOG performance 0-2
* informed consent

Exclusion Criteria

* active cellulitis/skin infection of the limb
* venous thrombosis of the upper limbs
* active malignancy
* any other medical condition or congenital or traumatic injury involving either limb
* patients already on selenium medication
* patients participating in another clinical study related to lymphedema

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No