Radiation Induced Oral MucositisNCT07748442
Benzydamine vs Supersaturated Calcium Phosphate Oral Rinses for Radiation Induced Oral Mucositis in Head and Neck Cancer Patients.
A study testing Benzydamine hydrochloride mouthrinse and Super saturated calcium phosphate oral rinses in people with Radiation Induced Oral Mucositis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Radiation Induced Oral Mucositis
- What is being tested?
- Benzydamine hydrochloride mouthrinse and Super saturated calcium phosphate oral rinses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Apr 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with poorly controlled diabetes mellitus
- Patients with prior xerostomia
- Patients with a history of chemo/radiotherapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Post Graduate Medical Institute, Lahore.
Lahore, Punjab Province, 54000
About this study
Official title: COMPARISON Between TWO MOUTHWASHES in the Prevention and Management of ORAL MUCOSITIS During RADIOTHERAPY of HEAD AND NECK CANCER Patients.
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.
Read the detailed description
42 patients of either gender and age group 30-70 years with head and neck cancer will be selected. Informed consent will be obtained from all the patients (Annex-I, Annex-II). Selected patients will have no history of previous radiotherapy or any other major systemic disease. There will be no evidence of oral mucositis before the commencement of study. The patients will be assigned into two groups by non-probability convenient sampling and their study groups will be as follows:
Groups Number of patients Oral Rinse to be Used A 21 Benzydamine Hydrochloride B 21 Super saturated calcium phosphate solution Patients will be examined before starting radiotherapy. Radiation therapy will be started at a dose of 2 Gray per fraction for 5 days a week up to a total dose of 50-70 Grays in total 6 weeks.
In the experimental group1patients will be asked to rinse with 15 ml benzydamine hydrochloride solution for three times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).
In the experimental group 2 patients will be asked to rinse with 30 ml supersaturated calcium phosphate solution for four times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).supersaturated calcium phosphate solution will be prepared and dispensed(Annex III). It will be stored at room temperature.
Examination of oral mucosa will be performed on all patients at the beginning of treatment and will be continued weekly up to the end of radiotherapy (6 weeks) by visual assessment. Grade 0-4 of oral mucositis by WHO will be assessed using battery operated light.
Whole saliva sample will be collected from each participant of both the groups before the commencement of radiotherapy. Participants will rinse their mouth and then 3mL of whole saliva will be collected in disposable test tubes. Samples will be refrigerated at -80°c until ELISA is performed to quantify MIF levels. Saliva sample will also be collected after 3 weeks of end of radiotherapy and will be stored following the same protocol.
MIF quantification will be done by sandwich ELISA method (BioLegend® Legend Max TM Human Active MIF, Cat. No. 438408) according to manufacturer's instructions.
Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen.
Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink.
Study Variables
Qualitative variable:
- Onset and Severity/progression of Oral Mucositis WHO scale for grading oral mucositis (Cheng and Yeun., 2006) Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen.
Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink.
Statistical Analysis The data will be entered and analyzed using SPSS25 (full form). Normality of data will be calculated by Shapiro Wilk test. The quantitative data will be analyzed using Student-T test to determine the mean difference in quantitative variables between groups. Mean ± SD will be given for quantitative variable (ELISA macrophage migratory inhibitory factor levels). Chi square test will be used for analysis of qualitative variable (The onset and severity of oral mucositis). A p- value of ≤ to 0.05 will be considered significant.
- Conditions
- Radiation Induced Oral Mucositis
- Being tested
- Benzydamine hydrochloride mouthrinse, Super saturated calcium phosphate oral rinses
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzydamine hydrochloride mouthrinseDrug
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
Super saturated calcium phosphate oral rinsesDrug
salivary Macrophage migratory inhibitory factors will be assessed before and after radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A Benzydamine group | Experimental | group A will use benzydamine oral rinses throughout their radiation treatment Receives: 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 Receives: Drug: Super saturated calcium phosphate oral rinses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start13 Apr 2022
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Induced Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humaira Batool, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748442
- Sponsor's protocol ID
- UHS/Education/126-22/2344
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient's gender, age, oral mucositis grades and levels of salivary macrophage migration inhibitory factor.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON Between TWO MOUTHWASHES in the Prevention and Management of ORAL MUCOSITIS During RADIOTHERAPY of HEAD AND NECK CANCER Patients.
- ClinicalTrials.gov ID
- NCT07748442
- Acronym / sponsor ID
- UHS/Education/126-22/2344
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
42 patients of either gender and age group 30-70 years with head and neck cancer will be selected. Informed consent will be obtained from all the patients (Annex-I, Annex-II). Selected patients will have no history of previous radiotherapy or any other major systemic disease. There will be no evidence of oral mucositis before the commencement of study. The patients will be assigned into two groups by non-probability convenient sampling and their study groups will be as follows:
Groups Number of patients Oral Rinse to be Used A 21 Benzydamine Hydrochloride B 21 Super saturated calcium phosphate solution Patients will be examined before starting radiotherapy. Radiation therapy will be started at a dose of 2 Gray per fraction for 5 days a week up to a total dose of 50-70 Grays in total 6 weeks.
In the experimental group1patients will be asked to rinse with 15 ml benzydamine hydrochloride solution for three times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).
In the experimental group 2 patients will be asked to rinse with 30 ml supersaturated calcium phosphate solution for four times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).supersaturated calcium phosphate solution will be prepared and dispensed(Annex III). It will be stored at room temperature.
Examination of oral mucosa will be performed on all patients at the beginning of treatment and will be continued weekly up to the end of radiotherapy (6 weeks) by visual assessment. Grade 0-4 of oral mucositis by WHO will be assessed using battery operated light.
Whole saliva sample will be collected from each participant of both the groups before the commencement of radiotherapy. Participants will rinse their mouth and then 3mL of whole saliva will be collected in disposable test tubes. Samples will be refrigerated at -80°c until ELISA is performed to quantify MIF levels. Saliva sample will also be collected after 3 weeks of end of radiotherapy and will be stored following the same protocol.
MIF quantification will be done by sandwich ELISA method (BioLegend® Legend Max TM Human Active MIF, Cat. No. 438408) according to manufacturer's instructions.
Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen.
Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink.
Study Variables
Qualitative variable:
- Onset and Severity/progression of Oral Mucositis WHO scale for grading oral mucositis (Cheng and Yeun., 2006) Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen.
Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink.
Statistical Analysis The data will be entered and analyzed using SPSS25 (full form). Normality of data will be calculated by Shapiro Wilk test. The quantitative data will be analyzed using Student-T test to determine the mean difference in quantitative variables between groups. Mean ± SD will be given for quantitative variable (ELISA macrophage migratory inhibitory factor levels). Chi square test will be used for analysis of qualitative variable (The onset and severity of oral mucositis). A p- value of ≤ to 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Benzydamine group | Experimental | Drug: Benzydamine hydrochloride mouthrinsegroup A will use benzydamine oral rinses throughout their radiation treatment |
| Group B super saturated calcium phosphate group | Experimental | Drug: Super saturated calcium phosphate oral rinsesgroup B will use super saturated calcium phosphate oral rinses throughout their radiation treatment |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with poorly controlled diabetes mellitus
- Patients with prior xerostomia
- Patients with a history of chemo/radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzydamine hydrochloride mouthrinseComparison of Salivary macrophage migratory inhibitory factor through ELISA in both the intervention groups and observing onset and severity of oral mucositis in both groups | Drug | Group A Benzydamine group |
| Super saturated calcium phosphate oral rinsessalivary Macrophage migratory inhibitory factors will be assessed before and after radiation therapy | Drug | Group B super saturated calcium phosphate group |
Primary outcome
Salivary macrophage migratory inhibitory Levels
Time frame: Two readings will be taken. 1st Baseline at day Zero (before start of radiotherapy) . 2nd at 3 weeks postradiotherapy.
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
Grade of Oral mucositis.
Time frame: 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.
Oral musocositis grade will be assessed in both groups at weekly interval.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Patient's gender, age, oral mucositis grades and levels of salivary macrophage migration inhibitory factor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benzydamine hydrochloride mouthrinse and Super saturated calcium phosphate oral rinses in people with Radiation Induced Oral Mucositis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary macrophage migratory inhibitory Levels (time frame: Two readings will be taken. 1st Baseline at day Zero (before start of radiotherapy) . 2nd at 3 weeks postradiotherapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.