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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

NCT00001812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2008-03-04

No results posted yet for this study

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.

Conditions

  • Candidiasis, Oral
  • Gastrointestinal Diseases
  • Stomatitis

Interventions

DRUG

Nystatin

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-04-30
Completion
2000-08-31

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 NCT00001812 on ClinicalTrials.gov