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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

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ClinicalTrials.gov Identifier: NCT00001812
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Gastrointestinal Diseases Stomatitis Drug: Nystatin Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Primary Purpose: Treatment
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
Study Start Date : April 1999
Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Nystatin





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001812


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)

Publications:
ClinicalTrials.gov Identifier: NCT00001812     History of Changes
Other Study ID Numbers: 990097
99-C-0097
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: April 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Mucositis
Oral Candidiasis
Prophylaxis
Stomatitis
Swish and Swallow

Additional relevant MeSH terms:
Candidiasis
Gastrointestinal Diseases
Digestive System Diseases
Stomatitis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases
Interleukin-2
Nystatin
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action