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Amifostine for Head and Neck Irradiation in Lymphoma

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Non-Hodgkin's Lymphoma
Hodgkin's Disease
Lymphoma

Treatments

Drug: Amifostine
Radiation: Radiation Therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

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)

75 participants in 2 patient groups

Group 1
Active Comparator group
Description:
Amifostine plus radiation therapy
Treatment:
Radiation: Radiation Therapy
Drug: Amifostine
Group 2
Active Comparator group
Description:
Radiation therapy alone
Treatment:
Radiation: Radiation Therapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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