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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200722005
Enrollment
70
Registered
2020-07-22
Start date
2020-03-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

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

Interventions

There are clinical trials provide data of povidone iodine gargling can be used to prevent oral mucositis after chemoradiation for head and neck cancer patients.,Benzydamine hydrochloride or Difflam®
Experimental Drug,Active Comparator Drug
Povidone iodine gargling,Benzydamine hydrochloride

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Oral mucositis Weekly after received concurrent chemoradiation until finish treatment 2-4 week (2-8 weeks) Oral mucositis assessment scale (OMAS)—

Secondary

MeasureTime frame
Satisfaction at first and last treatment with oral rinse Satisfactory assessment—

Countries

Thailand

Contacts

Public ContactChanida Vinayanuwattikun

Medical oncology department, faculty of medicine, Chulalongkorn university

nutechu@gmail.com022564533

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026