Benzydamine vs Supersaturated Calcium Phosphate Oral Rinses for Radiation Induced Oral Mucositis in Head and Neck Cancer Patients.

NCT07748442 | Completed

• 1 other identifier: UHS/Education/126-22/2344
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare and correlate salivary macrophage migratory inhibitory factor levels with onset and severity of radiation induced mucositis in head and neck cancer patients by using super saturated calcium phosphate solution and benzydamine hydrochloride oral rinses. Participants are patients of head and neck cancers undergoing radiation therapy of either gender. participants are divided into two groups Group A: Benzydamine group Group B: Super saturated calcium phosphate group

• Participants will be using Oral rinses of their respective group and will be assessed for radiation induced oral mucositis at weekly intervals during radiation treatment.
• salivary Macrophage migratory inhibitory factor levels will be assessed through ELISA, before and after the radiation treatment as per protocol.

Conditions

Radiation Induced Oral Mucositis

Keywords

radiation induced oral mucositis; super saturated calcium phosphate oral rinses; benzydamine hydrochloride mouth wash; salivary macrophage migratory inhibitory factor levels in Radiation induced oral mucositis

Outcome Measures

Primary Outcomes (2)

• Salivary macrophage migratory inhibitory Levels

  Salivary macrophage migratory inhibitory Levels will be assessed before the start of radiotherapy and 3 weeks after the completion radiation therapy for each patient in both the groups

  Two readings will be taken. 1st Baseline at day Zero (before start of radiotherapy) . 2nd at 3 weeks postradiotherapy.

• Grade of Oral mucositis.

  Oral musocositis grade will be assessed in both groups at weekly interval.

  Assessment at day zero before start of radiotherapy. Assessment at week 1. Assessment at week 2. Assessment at week 3. Assessment at week 4. Assessment at week 5. Assessment at week 6, the end of radiotherapy.

Study Arms (2)

Group A Benzydamine group

EXPERIMENTAL

group A will use benzydamine oral rinses throughout their radiation treatment

Drug: Benzydamine hydrochloride mouthrinse

Group B super saturated calcium phosphate group

EXPERIMENTAL

group B will use super saturated calcium phosphate oral rinses throughout their radiation treatment

Drug: Super saturated calcium phosphate oral rinses

Interventions

Benzydamine hydrochloride mouthrinse DRUG

Comparison of Salivary macrophage migratory inhibitory factor through ELISA in both the intervention groups and observing onset and severity of oral mucositis in both groups

Group A Benzydamine group

Super saturated calcium phosphate oral rinses DRUG

salivary Macrophage migratory inhibitory factors will be assessed before and after radiation therapy

Group B super saturated calcium phosphate group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender (age group 30-70 years) with any histological type of head and neck cancers having a treatment plan to receive radiotherapy.

You may not qualify if:

• Patients with poorly controlled diabetes mellitus
• Patients with prior xerostomia
• Patients with a history of chemo/radiotherapy

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

Post Graduate Medical Institute, Lahore.

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 5, 2026
• Study Start: April 13, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)