Pain Reduction, Feasibility, and Quality of Life of 2% Lidocaine Spray versus 2% Lidocaine Oral Viscous for Head and Neck Cancer Patients with Chemoradiation-Induced Mucositis: A Randomized phase 2 study

Pain Reduction, Feasibility, and Quality of Life of 2% Lidocaine Spray versus 2% Lidocaine Oral Viscous Solution for Squamous cell carcinoma of Head and Neck Cancer Patients with Chemoradiation-Induced Mucositis: A Randomized controlled study

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241115007

Enrollment

Registered

2024-11-15

Start date

2023-05-30

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

Patients undergoing dCCRT with cisplatin for squamous cell carcinoma of head and neck cancers at Siriraj Hospital with mucositis definite CCRT with cisplatin Squamous cell of head and neck cancer Mucositis Accumulated average radiation dose more than 20 Gy

Interventions

Type: Spray Usage: Spray using the long nozzle directly to the affected area and administer 4 to 8 puffs at a time. Spray before meals, 2 to 3 minutes prior, or can be reapplied every hour when experi

Experimental Drug,Active Comparator Drug

2% Peppermint lidocaine spray,2% lidocaine oral viscous

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients undergoing dCCRT with cisplatin for squamous cell carcinoma of head and neck cancers at Siriraj Hospital. 2. Patients with Mucositis more than gr 2 (as assessed by CTCAE version 5.0) or more than gr 1 accompanied by mouth and throat pain 3. Patients with an accumulated average radiation dose to the oral mucosa of more than 20 Gy 4. Patients or their caregivers can provide informed consent and respond to the interview

Exclusion criteria

Exclusion criteria: 1.Patients uncontrolled infection, fistula, wound dehiscence of the buccal mucosa, or active bleeding disorders. 2. Patients with a history of radiation therapy to the head and neck areas. 3. Patients with a history of allergy to lidocaine 4. Pregnant or lactating patients. 5. Patients who did not adhere to follow-up appointments and interview

Design outcomes

Primary

Measure	Time frame
Immediate pain reduction at 0 and 5 minutes 0,5 minutes Pain score	—

Secondary

Measure	Time frame
Feasibility End of the study Patient reported outcome using a questionnaire interview,Quality of life every Friday or on the last RT day of the week. Patient reported outcome using a questionnaire interview OMWQHN	—

Countries

Thailand

Contacts

Public ContactJomjit Chantharasamee

Faculty of Medicine Siriraj Hospital Mahidol University

jomjit025@gmail.com0631962941

Outcome results

None listed

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