Comparative efficacy of povidone-iodine gargling to benzydamine hydrochloride (Difflam®) to prevent oral mucositis from chemoradiotherapy in localized stage head and neck cancer

Phase 2

Recruiting

• Conditions: Patient with locally advanced head and neck cancer with plan treatment with definite concurrent chemoradiation or post operative chemoradiationAge ≥ 18 years; Povidone iodine; Difflam®; Oral Mucositis; Concurrent chemoradiation; Locally advanced head and neck cancer

• Registration Number: TCTR20200722005
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-22
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Be ≥18 years of age on day of signing informed consent.
Locally advanced head and neck cancer
ECOG performance status of 0 or 1
Plan received definite or postoperative concurrent chemoradiation with Cisplatin or Carboplatin
No history of allergy to Povidone iodine or Difflam®

Exclusion Criteria

Primary tumour at larynx, salivary gland, nasal cavity or paranasal sinus
Pregnant or breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral mucositis Weekly after received concurrent chemoradiation until finish treatment 2-4 week (2-8 weeks) Oral mucositis assessment scale (OMAS)

Secondary Outcome Measures

Name	Time	Method
Satisfaction at first and last treatment with oral rinse Satisfactory assessment