Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
Conditions
Keywords
Lymphoma, Radiation therapy, Amifostine
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.
Interventions
DRUGAmifostine
Given 30-60 minutes prior to daily radiation therapy
RADIATIONRadiation Therapy
Daily radiation therapy
Sponsors
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
MedImmune LLC
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To determine the quality-of-life of patients receiving radiation therapy and amifostine | — |
| to determine the safety of amifostine | 2 years |
Countries
United States
Outcome results
None listed