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Completed

NCT Number: NCT00136474

Amifostine for Head and Neck Irradiation in Lymphoma

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

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amifostine

Drug

Given 30-60 minutes prior to daily radiation therapy

radiation therapy

Radiation

Daily radiation therapy

Primary outcomes

  1. To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects

    Time frame: 2 years

Secondary outcomes

  1. To determine the quality-of-life of patients receiving radiation therapy and amifostine

  2. to determine the safety of amifostine

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • MedImmune LLC

Registry information

Official study title

A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma

Important dates

Study start
2003
Primary completion
2005
Study completion
2009
First posted
Aug 29, 2005
Registry last updated
Nov 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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