NCT00136474

Amifostine for Head and Neck Irradiation in Lymphoma

A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.

Detailed description

Patients will be randomized into one of two study groups. One study group will receive amifostine prior to daily radiation therapy and the other group will receive radiation therapy alone. Amifostine will be administered 30-60 minutes prior to radiation treatment. Vital signs will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately following radiation treatment. Patients will also complete a quality-of-life questionnaire on the first and last day of radiation treatment. Follow-up questionnaires will be done at follow-up visits 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy. Patients will be removed from the study if they develop an allergic reaction to amifostine.

Conditions

• Lymphoma
• Hodgkin's Disease
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Amifostine	Given 30-60 minutes prior to daily radiation therapy
RADIATION	Radiation Therapy	Daily radiation therapy

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-05-01
• Completion: 2009-03-01
• First posted: 2005-08-29
• Last updated: 2009-11-02

Locations

2 sites across 1 country: United States