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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05323058

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomatitis	Drug: tulsi extract Drug: Benzydamine Hydrochloride	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Allocation ratio (1:1)Allocation ratio (1:1)

Masking:

Double (Participant, Investigator)

Masking Description:

The principal investigator and participant will be blinded as the treatment preparations will be identical in color, odor, and consistency and they will be placed in identical bottles

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Severity of mucositis [up to 15 days]
Oral Mucositis Assessment Scale (OMAS)

Secondary Outcome Measures

Pain and burning sensation [up to 15 days]
assess by numerical rating scale (NRS) (10 points scale)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.