Selenium in the Treatment of Complicated Lymphatic Malformations

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Hypotheses:

* 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.

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Detailed Description

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Conditions

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Lymphatic Malformations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Selenium

400 μg once a day for 6 months by mouth

Intervention Type DRUG

Other Intervention Names

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Selenase

Eligibility Criteria

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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.
* 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

Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No