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

Phase 4

Withdrawn

• Conditions: Stomatitis; Oral Mucositis
• Interventions: Radiation: Amifostine

• Registration Number: NCT01288625
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Amifostine	Radiation treatment 1.8-2.0 Gy/day × 30-35 times
Cytofos group A	Amifostine	Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
Cytofos group B	Amifostine	Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times

Primary Outcome Measures

Name	Time	Method
Incidence and duration of oral mucositis	3 months