Amifostine for Head and Neck Irradiation in Lymphoma

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Disease; Lymphoma

Treatments: Radiation: Radiation Therapy; Drug: Amifostine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00136474

02-292

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Amifostine plus radiation therapy

Treatment:

Drug: Amifostine

Radiation: Radiation Therapy

Group 2

Active Comparator group

Description:

Radiation therapy alone

Treatment:

Radiation: Radiation Therapy