We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001812
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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 Intervention Phase
Candidiasis, Oral Gastrointestinal Diseases Stomatitis Drug: Nystatin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 84
Study Start Date: April 1999
Estimated Study Completion Date: August 2000
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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.

  Contacts and Locations
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)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001812     History of Changes
Other Study ID Numbers: 990097
99-C-0097
First Submitted: November 3, 1999
First Posted: December 10, 2002
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