Clinical trial NCT00136474: Amifostine for Head and Neck Irradiation in Lymphoma
Official title: A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Keywords: Lymphoma
Radiation therapy
Amifostine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: MedImmune LLC
First posted: 2005-08-29
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
timeFrame: 2 years
Secondary outcomes:
measure: To determine the quality-of-life of patients receiving radiation therapy and amifostine
measure: to determine the safety of amifostine
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea K. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: