CompletedNot Applicable

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

Pakistan42 participantsStarted 2022-04-13

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients with poorly controlled diabetes mellitus * Patients with prior xerostomia * Patients with a history of chemo/radiotherapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Salivary macrophage migratory inhibitory Levels

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

Grade of Oral mucositis.

Timeframe: 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.

Trial details

NCT IDNCT07748442

SponsorPostgraduate Medical Institute, Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Radiation Induced Oral Mucositis trials