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Completed

NCT Number: NCT00188604

The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

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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Key information

Conditions

Breast Neoplasms Breast Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium selenite

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. To assess the toxicity of selenium.

  2. To assess the association of selenium, quality of life and limb function.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Aug 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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