Subcutaneous Amifostine Safety Study

Mt. Sinai Medical Center, Miami452 enrolled

Overview

Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

452

Conditions

Head and Neck Cancer Lung Cancer Lymphoma

Interventions

Amifostine administered subcutaneouslyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Institutional criteria for administration of amifostine * Radiation therapy * ECOG PS of at least 2 * No distant mets * Granulocyte count greater than 2000 * Platelet count greater than 100,000 * Creatinine less than 2.0 Exclusion Criteria: * Allergy to amifostine * Life expectancy less than 6 mos * Investigational drug within last 4 weeks

Locations (1)

Mt. Sinai Medical Center

Miami Beach, Florida, United States

Outcomes

Primary Outcomes

Incidence of nausea/vomiting

Incidence of hypotension

Incidence of generalized skin rash

Incidence of injection-site skin toxicity

Data from ClinicalTrials.gov

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