Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288625

Enrollment

Registered

2011-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-17

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

Conditions

Oral Mucositis, Stomatitis

Keywords

Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.

Brief summary

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.

Interventions

DRUGAmifostine

500 mg sc, qod, 3 times per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. 18-70 years old, male or female 2. Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis 3. Postoperative patients should receive radiation treatment in 12 weeks 4. ECOG \<2 5. Expected lifetime ≥6months 6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.) 7. Not involved in other clinical trials 8. Sign ICF

Exclusion criteria

1. ECOG \>2 2. Suffered other cancers in the past 5 years 3. Received amifostine treatment in the past 4 weeks 4. Unable to complete treatment or sign ICF because of medical or physical reasons

Design outcomes

Primary

Measure	Time frame
Incidence and duration of oral mucositis	3 months

Outcome results

None listed

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