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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| MedImmune LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Amifostine plus radiation therapy |
|
| Group 2 | Active Comparator | Radiation therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amifostine | Drug | Given 30-60 minutes prior to daily radiation therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the quality-of-life of patients receiving radiation therapy and amifostine | ||
| to determine the safety of amifostine | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea K. Ng, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004999 | Amifostine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Radiation Therapy |
| Radiation |
Daily radiation therapy |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D013812 | Therapeutics |