Subcutaneous Amifostine Safety Study

Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158041

Enrollment

452

Registered

2005-09-12

Start date

2002-01-31

Completion date

2005-01-31

Last updated

2005-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Lung Cancer, Lymphoma

Keywords

Amifostine, Mucositis, Nausea, Hypotension, Rash

Brief summary

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.

Interventions

DRUGAmifostine administered subcutaneously

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of nausea/vomiting	—
Incidence of hypotension	—
Incidence of generalized skin rash	—
Incidence of injection-site skin toxicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026