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Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis

NCT00075023 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-11-04

Study results available
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Summary

This study was designed to be conducted in 2 parts. The first part is a pilot study to test the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who have developed oral chronic graft-versus-host-disease (cGVHD)-related ulcerative stomatitis following allogeneic bone marrow/peripheral blood stem cell transplant (HSCT). Chronic GVHD may be related to increased levels of a cytokine called TNF-alpha (TNFa) following HSCT. Thalidomide's anti-inflammatory effects may lower TNFa levels, lead to healing of these oral ulcers, and decrease oral pain.

If the pilot study is successful, the second part of the study will be done. This will test the effects of a 0.1% (20mg) thalidomide mouthwash in treating oral cGVHD-related stomatitis in patients following allogeneic HSCT. Applying thalidomide directly to the GVHD-related mouth ulcer in gel form or to the entire oral cavity in mouthwash form rather than taking it in pill form may reduce the amount of drug that enters the blood stream and cause less side effects.

In the pilot study, participants will be randomly assigned to receive thalidomide gel 20mg or placebo (identical gel with no thalidomide) to use 4 times a day for 4 weeks. In the mouthwash study, participants will be randomly assigned to receive 0.1% 20mg thalidomide mouthwash or placebo (identical mouth rinse with no thalidomide) to use 4 times a day for 4 weeks. Participants will undergo the following procedures before beginning experimental treatment, then once a week for 4 weeks, and then approximately 8 weeks after the first visit:

* Interview about current medications and use of alcohol and cigarettes
* Self-report of mouth and throat pain
* Oral examination for stomatitis rating, and oral ulcer(s) measurement
* Quality of life questionnaire (repeated only at week 8 of the study)
* Mouth photography to measure and record the oral ulcer response to treatment
* Saliva sampling to look for proinflammatory cytokines (small proteins), including TNFa
* Oral ulcer exudate collected by filter paper to obtain fluid for measuring TNFa levels
* Gentle swabbing of oral ulcers to culture for virus, fungus, and bacteria that may be present
* Small punch biopsy of the area near the ulcer or affected area to check for presence of TNFa (repeated only at week 4 of the study)
* Blood sampling to monitor TNFa levels
* A urine pregnancy test for women who are able to have children (repeated at weeks 2, 4, and 8)

Conditions

Interventions

DRUG

Thalidomide Gel

DRUG

Placebo Gel

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    lead NIH

Principal Investigators

  • Jane Fall-Dickson, RN, PhD · NIH/NINR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00075023 on ClinicalTrials.gov