Amifostine for Head and Neck Irradiation in Lymphoma

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

Detailed Description
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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.

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

Conditions
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Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Amifostine
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 35 years or older Histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma receiving radiation therapy to the head and neck area. Involvement of one or more of the following sites: cervical node, supraclavicular node, pre-auricular node, submental node, any salivary glands, any parts of the oral cavity, or any parts of the oropharynx. Exclusion Criteria: Prior history of head and neck malignancies Prior radiation therapy to the head and neck region Patients with stage I Hodgkin's disease receiving radiation therapy alone Pregnant or lactating women Myocardial infarction within the 6 months of enrollment Clinically evident pulmonary insufficiency, except for patients with exertional dyspnea related to chest tumor itself.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Amifostine plus radiation therapy | Drug: Amifostine<br>* Given 30-60 minutes prior to daily radiation therapy<br>Radiation: Radiation Therapy<br>* Daily radiation therapy<br>|
| Active Comparator: Group 2<br>Radiation therapy alone | Radiation: Radiation Therapy<br>* Daily radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the quality-of-life of patients receiving radiation therapy and amifostine |  |  | 
| to determine the safety of amifostine |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Radiation therapy, Amifostine