Oral Submucous Fibrosis Clinical Trial
— MROSFOfficial title:
Repurposing Metformin for the Treatment of Oral Submucous Fibrosis: Unraveling Novel Signaling Pathways In Vitro and Advancing to Clinical Trial"
OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Patients with OSF- palpable bands on oral examination 2. Patients with limited mouth opening due to OSF 3. Patients who have not received any treatment for OSF in the previous three months 4. Patients with habits of pan, Chalia, Ghutka 5. Age group between 18 and 45 years Exclusion Criteria: 1. Patients presenting with both OSCC and OSF 2. Patients with limited mouth opening due to impaction of the third molar (impaction of third molar results in limited mouth opening hence such patients are excluded since limited mouth opening due to third molar impaction can be mistaken for OSF). 3. Patients with limited mouth opening due to temporomandibular joint disorder (temporomandibular joint disorders can limit the ability of patient to open their mouth and hence can be mistaken for OSF) 4. Any history of Metformin intolerance or contraindications. 5. Presence of other severe medical conditions along with drug therapy. 6. Pregnancy or lactation. 7. Participation in other clinical trials concurrently. 8. Inability to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Ziauddin University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Ziauddin University |
Pakistan,
Pimentel I, Lohmann AE, Ennis M, Dowling RJO, Cescon D, Elser C, Potvin KR, Haq R, Hamm C, Chang MC, Stambolic V, Goodwin PJ. A phase II randomized clinical trial of the effect of metformin versus placebo on progression-free survival in women with metasta — View Citation
Septembre-Malaterre A, Boina C, Douanier A, Gasque P. Deciphering the Antifibrotic Property of Metformin. Cells. 2022 Dec 16;11(24):4090. doi: 10.3390/cells11244090. — View Citation
Shen YW, Shih YH, Fuh LJ, Shieh TM. Oral Submucous Fibrosis: A Review on Biomarkers, Pathogenic Mechanisms, and Treatments. Int J Mol Sci. 2020 Sep 30;21(19):7231. doi: 10.3390/ijms21197231. — View Citation
Teague TT, Payne SR, Kelly BT, Dempsey TM, McCoy RG, Sangaralingham LR, Limper AH. Evaluation for clinical benefit of metformin in patients with idiopathic pulmonary fibrosis and type 2 diabetes mellitus: a national claims-based cohort analysis. Respir Re — View Citation
Wu M, Xu H, Liu J, Tan X, Wan S, Guo M, Long Y, Xu Y. Metformin and Fibrosis: A Review of Existing Evidence and Mechanisms. J Diabetes Res. 2021 Apr 29;2021:6673525. doi: 10.1155/2021/6673525. eCollection 2021. — View Citation
Yang SF, Wang YH, Su NY, Yu HC, Wei CY, Yu CH, Chang YC. Changes in prevalence of precancerous oral submucous fibrosis from 1996 to 2013 in Taiwan: A nationwide population-based retrospective study. J Formos Med Assoc. 2018 Feb;117(2):147-152. doi: 10.101 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cell Viability | Cell Viability by MTT Assay Unit: Percentage Assessment of cell viability will be reported as a percentage of untreated control cells. | 8 months | |
Primary | Cytotoxicity | Cytotoxicity Unit: Percentage Measurement of cytotoxicity will be presented as a percentage relative to untreated control cells. | 8 Months | |
Primary | Morphological Changes Cell Shape | Unit: Qualitative description Cell shape alterations will be described qualitatively based on microscopic observations. | 8months | |
Primary | Morphological Change Cell Density | Unit: Cells per unit area Changes in cell density will be quantified and reported as cells per unit area. Sub-Measure 3: Extracellular Matrix (ECM) Structure Unit: Qualitative description Alterations in ECM structure will be qualitatively assessed. | 8 months | |
Primary | Morphological Change Extracellular Matrix (ECM) Structure | Extracellular Matrix (ECM) Structure Unit: Qualitative description Alterations in ECM structure will be qualitatively assessed. | 8 months | |
Primary | Cell Migration Assays | Unit: Distance migrated (micrometers) The extent of cell migration will be quantified as the distance migrated from the original point. | 8months | |
Primary | Cell Invasion Assays | Unit: Invaded area (e.g., square millimeters) Assessment of cell invasion will be presented as the invaded area relative to untreated control cells. | 8 months | |
Primary | Apoptosis Analysis | Unit: Percentage Apoptotic cells will be quantified and reported as a percentage of the total cell population. | 8months | |
Primary | Assess Signaling pathway with optimal metformin concentration | To evaluate the effect of TGF-beta Smad 2/3 and wnt/b-catenin signaling pathways in vitro | 9 months | |
Secondary | Clinical Oral Mucosal Characteristics | Unit: Descriptive score (based on a scale ranging from 0 to 3 (normal to severe).0=No changes 1=Soreness 2=Soreness and ulceration 3=Soreness, ulceration and ability to use a liquid diet only | 9 months | |
Secondary | Patient Burning sensation pain | Unit: Units on a scale (Verbal numeric rating scale graded on a 10-point scale from 0 to 10, where 0 indicated no burning sensation while 10 represented the worst burning sensation) | 9 months | |
Secondary | Patient Mouth Opening | Unit: Millimeters on a scale of Grade 0 = > 35 mm, Grade1= 26-35mm, Grade 2= 15-25mm, Grade 3: < 10mm | 9 months |
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