The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
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ClinicalTrials.gov Identifier: NCT00188604 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : August 13, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms Lymphedema | Drug: sodium selenite | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188604
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Wilfred Levin, MD | Princess Margaret Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT00188604 |
Other Study ID Numbers: |
UHN REB 03-0741-C |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | August 13, 2010 |
Last Verified: | August 2010 |
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Lymphatic Diseases Selenious Acid Sodium Selenite Trace Elements Micronutrients Physiological Effects of Drugs |