Amifostine for Head and Neck Irradiation in Lymphoma

Dana-Farber Cancer Institute75 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma Hodgkin's Disease Non-Hodgkin's Lymphoma

Interventions

AmifostineDRUG

Given 30-60 minutes prior to daily radiation therapy

Radiation TherapyRADIATION

Daily radiation therapy

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects

Time frame: 2 years

Secondary Outcomes

To determine the quality-of-life of patients receiving radiation therapy and amifostine

to determine the safety of amifostine

Time frame: 2 years

Data from ClinicalTrials.gov

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