NCT00158691

Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas

A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (planned)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

Detailed description

Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Ethyol

Timeline

• Start date: 2001-03-01
• First posted: 2005-09-12
• Last updated: 2005-09-12

Locations

1 site across 1 country: France