Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas

A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158691

Enrollment

296

Registered

2005-09-12

Start date

2001-03-31

Completion date

Unknown

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

Keywords

Head and Neck cancer, Radiotherapy, Xerostomia, Randomized trial

Brief summary

Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

Detailed description

Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

Interventions

DRUGEthyol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* newly diagnosed squamous cell head and neck cancer * inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy * Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine \< 130 / mmol.L-1, Transaminase ≤ 3 x upper limit

Exclusion criteria

* Distant metastases * Prophylactic use of pilocarpine * Concomitant chemotherapy

Design outcomes

Primary

Measure	Time frame
Late xerostomia rate	—

Countries

France

Outcome results

None listed

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