Trials / Completed
CompletedNCT00001812
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (planned)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.
Detailed description
In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nystatin |
Timeline
- Start date
- 1999-04-01
- Completion
- 2000-08-01
- First posted
- 2002-12-10
- Last updated
- 2008-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00001812. Inclusion in this directory is not an endorsement.