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

NCT01288625 | Withdrawn Phase 4

• 1 other identifier: SUN-2011-DP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Oral Mucositis; Stomatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence and duration of oral mucositis

  3 months

Study Arms (3)

Cytofos group A

EXPERIMENTAL

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

Drug: Amifostine; Radiation: Amifostine

Cytofos group B

EXPERIMENTAL

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

Drug: Amifostine; Radiation: Amifostine

Control group

ACTIVE COMPARATOR

Radiation treatment 1.8-2.0 Gy/day × 30-35 times

Drug: Amifostine; Radiation: Amifostine

Interventions

Amifostine DRUG

500 mg sc, qod, 3 times per week

Control group; Cytofos group A; Cytofos group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

MeSH Terms

Conditions

Stomatitis

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Wang ge

  Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Last Updated: November 17, 2021

Record last verified: 2021-11