The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy

Phase 2

• Conditions: Stomatitis
• Interventions: Drug: tulsi extract; Drug: Benzydamine Hydrochloride

• Registration Number: NCT05323058
• Lead Sponsor: Cairo University

Brief Summary

After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.

Detailed Description

the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days

Study Timeline

• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11
• Study Start: 2022-07
• Primary Completion: 2023-11
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV)
• Patient should be able to read and/or understand and sign the consent form.

Exclusion Criteria

1. Patients with HIV infections or hyperthyroidism.
2. Karnofsky performance status (KPS) less than 60%
3. Patients having an allergy to tulsi or benzydamine HCL
4. Patients who are pregnant and/or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tulsi extract	tulsi extract	4% tulsi extract as intervention
benzydamine hydrochloride	Benzydamine Hydrochloride	0.15% benzydamine hydrochloride

Primary Outcome Measures

Name	Time	Method
Severity of mucositis	up to 15 days	Oral Mucositis Assessment Scale (OMAS)

Secondary Outcome Measures

Name	Time	Method
Pain and burning sensation	up to 15 days	assess by numerical rating scale (NRS) (10 points scale)