Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Wounds and Injuries

Rare Diseases

Syndrome

Recurrence

Leukemia

Communicable Diseases

Preleukemia

Myelodysplastic Syndromes

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Hematologic Neoplasms

Hyperthermia

Neutropenia

Fever

Hodgkin Disease

Myeloproliferative Disorders

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Bone Marrow Diseases

Precancerous Conditions

Chronic Graft Versus Host Disease

Lymphosarcoma

Granulocytopenia

Hodgkin Lymphoma

Chronic Myeloproliferative Disorders

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amphotericin B

Liposomal amphotericin B

Clotrimazole

Miconazole

Deoxycholic Acid

Antifungal Agents

Nystatin

Amphotericin B, deoxycholate drug combination

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Anti-Bacterial Agents

Ionophores

amphotericin B deoxycholate

nystatin

David S. Gordon, MD

RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared with standard amphotericin B to treat fever and neutropenia in patients receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of drug-related toxicity or impairment and infusion-related toxicity in patients treated with liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of liposomal nystatin.

OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm II: Antifungal Therapy. Amphotericin B, NSC-527017.

PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS

Aronex Pharmaceuticals

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Pharmaceutical Solutions

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Dexamethasone

Tin Fluorides

Sucralfate

Dexamethasone acetate

Diphenhydramine

Promethazine

Benzydamine

Antacids

Anti-Ulcer Agents

Magic mouthwash will contain diphenhydramine powder 375mg, dexamethasone injection 2.8mg, and nystatin suspension 50ml (1000 units/ml) diluted to a total volume of 250ml with sterile water.

The concentration of the sucralfate suspension will be 1g/5ml.

Patients will be instructed to rinse first with 5ml of the magic mouthwash solution for 2 minutes then swallow, followed by rinsing with 5ml of the sucralfate suspension for 2 minutes before swallowing, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.

Combination of Magic Mouthwash Plus Sucralfate

Patients will rinse with 15ml of 1.5mg/ml benzydamine HCl for 2 minutes then expectorate the solution, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.

0.15% Benzydamine HCl

Joda Kuk, MD

Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15% benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.

Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.

Juravinski Cancer Centre Foundation

Dr. Joda Kuk, Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer	NCT00002742	Chronic Myelopr... Infection Leukemia Lymphoma Multiple Myelom... Myelodysplastic...	amphotericin B ... nystatin	2 Years -	National Cancer Institute (NCI)
Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis	NCT00814359	Head and Neck C... Mucositis	Combination of ... 0.15% Benzydami...	18 Years -	Juravinski Cancer Centre Foundation
Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis	NCT00814359	Head and Neck C... Mucositis	Combination of ... 0.15% Benzydami...	18 Years -	Juravinski Cancer Centre Foundation

Spots Global Cancer Trial Database for nystatin

Every month we try and update this database with for nystatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nystatin

Every month we try and update this database with for nystatin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nystatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.