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Selenium in the Treatment of Complicated Lymphatic Malformations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212965
Recruitment Status : Terminated (The investigators chose to terminate the study due to participant attrition. Of the limited data evaluable, none of the patients experienced adverse events.)
First Posted : October 1, 2010
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
Michael Kelly, Medical College of Wisconsin

Brief Summary:

The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials.


  • Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations
  • Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.

Condition or disease Intervention/treatment Phase
Lymphatic Malformations Drug: Selenium Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Selenium
    400 μg once a day for 6 months by mouth
    Other Name: Selenase

Primary Outcome Measures :
  1. Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations [ Time Frame: pretreatment and at 6 months ]
    Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.

  2. Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations [ Time Frame: throughout duration of study ]

Secondary Outcome Measures :
  1. Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome [ Time Frame: throughout duration of study ]
    Whole blood will be drawn prior to therapy and at specific time intervals after initiating selenium. Serum concentrations of selenium, selenium-dependent tripeptide glutathione and IL-20 will be measured and correlated with outcome

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have clinical and radiographic features consistent with a lymphatic malformation (LM). Patients with combined venous lymphatic malformations (CVLM) will be included if the predominant componet is lymphatic based on MRI. Both macrocystic and microcystic LM will be eligible. Tissue biopsy is required to confirm the presence of an abnormal lymphatic malformation.
  • All patients diagnosed with lymphatic malformations between 14 and 30 years of age will be eligible.
  • Patients must have lymphatic malformations with potential to cause morbidity including one or more of the following: Lymphedema, Coagulopathy, Chronic Pain, Recurrent Cellulitis (> 1 episodes/year), Ulceration and/or bleeding, Impairment of organ function, Visceral and/or bone involvement, or Disfigurement.
  • Patients receiving previous systemic therapy, surgical, debulking, or sclerotherapy will be eligible eight weeks following completion of therapy if they meet all inclusion criteria.
  • All patients and/or their parents or legal guardians must sign a written informed consent. All institutional FDA requirements for human studies must be met.

Exclusion Criteria:

  • Younger than 14 years of age or older than 30 years of age
  • Life-threatening complications related to LM
  • Patients with preexisting renal, hepatic, or thyroid disorders
  • Patients receiving a daily multivitamin supplement or other natural products that include selenium
  • Patients that have received previous selenium therapy will not be eligible
  • Women who are pregnant or breastfeeding

Information from the National Library of Medicine

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 identifier (NCT number): NCT01212965

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Principal Investigator: Michael E Kelly, MD, PhD Medical College of Wisconsin

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Responsible Party: Michael Kelly, Principal Investigator, Medical College of Wisconsin Identifier: NCT01212965    
Other Study ID Numbers: 10/93
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Michael Kelly, Medical College of Wisconsin:
Lymphatic Malformations
Additional relevant MeSH terms:
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Lymphatic Abnormalities
Congenital Abnormalities
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Lymphatic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances