A Phase 3 interventional study of Nystatin in Candidiasis, Oral, Gastrointestinal Diseases and Stomatitis, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment
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.
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 84 is below the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients enrolled on high dose intravenous interleukin-2 studies in the Surgery Branch of the National Cancer Institute are eligible, except for patients who are receiving adoptively transferred cells (cloned peripheral blood cells).
All inclusion criteria as stated in the parent immunotherapy protocol apply:
No patients with evidence of oral irritation prior to starting therapy;
No patients with any known sensitivity to nystatin;
No patients receiving systemic antifungals;
No patients with active oral infections.
In additional, all exclusion criteria as stated in the parent immunotherapy protocol.
This study is completed, as verified in Apr 2000. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)