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

The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stomatitis
• Intervention / Treatment: Drug: tulsi extract; Drug: Benzydamine Hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karima AbdAllah Kamel, PhD; Phone Number: +201014875386; Email: karima.kamel@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tulsi extract; 4% tulsi extract as intervention	Drug: tulsi extract; 4% topical oral spray
Active Comparator: benzydamine hydrochloride; 0.15% benzydamine hydrochloride	Drug: Benzydamine Hydrochloride; 0.15% topical oral spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of mucositis	Oral Mucositis Assessment Scale (OMAS)	up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and burning sensation	assess by numerical rating scale (NRS) (10 points scale)	up to 15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Assessment Guide (OAG)	Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene.	up to 15 days
Patient-Reported Oral Mucositis( PROMS scale)	Quality of life	up to 15 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: radiotherapy; oral mucositis; benzydamine hydrochloride; tulsi extract
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Anti-Inflammatory Agents; Benzydamine
• Other Study ID Numbers: tulsi in radiation mucositis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No