An interventional study of Benzydamine hydrochloride mouthrinse and Super saturated calcium phosphate oral rinses in Radiation Induced Oral Mucositis, sponsored by Postgraduate Medical Institute, Lahore. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Postgraduate Medical Institute, Lahore · Not applicable, Interventional, and Treatment
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
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:
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.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Postgraduate Medical Institute, Lahore is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
group A will use benzydamine oral rinses throughout their radiation treatment
Drug: Benzydamine hydrochloride mouthrinse
group B will use super saturated calcium phosphate oral rinses throughout their radiation treatment
Drug: Super saturated calcium phosphate oral rinses
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
salivary Macrophage migratory inhibitory factors will be assessed before and after radiation therapy
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
Time frame: 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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Patient's gender, age, oral mucositis grades and levels of salivary macrophage migration inhibitory factor.
Ran from Apr 2022 to primary completion in Mar 2023, 11 months.
Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's 11 months is below that.
Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Postgraduate Medical Institute, Lahore