Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
TerminatedPhase 2NCT00075023
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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), i…
Study details
- Official title
- Evaluation of Efficacy and Mechanisms of Topical Thalidomide for Chronic Graft-Versus-Host-Disease Related Stomatitis
- Conditions
- Graft-versus-Host Disease
- Stomatitis
- Interventions
- Drug: Thalidomide Gel
- Drug: Placebo Gel
- Sponsor
- National Institute of Nursing Research (NINR)
- Collaborators
- Fred Hutchinson Cancer Center
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 2003-12
- Primary completion
- 2010-04
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* INCLUSION CRITERIA: Participating in HSCT or cGVHD protocols and willing to participate in this study concurrently; Diagnosed with oral cGVHD stomatitis confirmed by surgical biopsy results; Oral ulceration present Able to understand and sign protocol informed consent; Ages 18 to 80 years of age. EXCLUSION CRITERIA: Pregnant or lactating females; For the proof of concept study, females who are not surgically sterilized by means of hysterectomy or tubal ligation; For the main study, females of childbearing potential who do not agree to the use of two forms of highly effective contraception for at least four weeks prior, during, and for four weeks following the last dose of study drug; Sexually active males who do not agree to the use of a latex condom while receiving study drug and for four weeks following the last dose of study drug; Unwilling to follow precautions for use of thalidomide; Unable to demonstrate appropriate use of study medication; Concurrent use of non-protocol-related medications confounding assessment of the inflammatory response (antihistamines, non-steroidal anti-inflammatory drugs); Allergic reaction to thalidomide; Pre-existing oral infection, which might maximize the possibility of an infection or sepsis contributing to a drug-related adverse event; Unwilling or unable to forego concurrent treatment for mucosal lesions and/or related oral pain (including topical steroids, viscous lidocaine, topical anti-fungals); Requiring addition of new systemic therapy including thalidomide, steroids, or radiation therapy; Use of sedatives (including CNS depressants); Absolute neutrophil count (ANC) less than 750/mm(3)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00075023