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A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Lymphedema

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Trial Information

A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.

Principal Investigator

Wilfred Levin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 03-0741-C

NCT ID:

NCT00188604

Start Date:

January 2004

Completion Date:

January 2009

Related Keywords:

  • Breast Neoplasms
  • Lymphedema
  • Breast Neoplasms
  • Neoplasms
  • Lymphedema

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