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 - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00001812. Last updated on March 3, 2008. Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	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
Official Title ^†	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
Brief 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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Candidiasis, Oral Gastrointestinal Diseases Stomatitis
Intervention ^†	Drug: Nystatin
MEDLINE PMIDs	1403839, 8642530, 3903508
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	84
Start Date ^†	April 1999
Completion Date	August 2000
Eligibility Criteria ^†	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001812
Organization ID	990097
Secondary IDs ^††	99-C-0097
Study Sponsor ^†	National Cancer Institute (NCI)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	April 2000
First Received Date ^†	November 3, 1999
Last Updated Date	March 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.