Clinical trial · Interventional
Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis
Pilot Study of Metformin (MF) IN HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC, to Investigate the Effects of MF, Tumor Genotype and MF Genotype Interactions, on Tumor Metabolism and Anoikis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding not available, PI left institution
Summary
Brief summary (as posted)
The study researchers want to look at the overall effects that Metformin may have on the tumor characteristics of Head and Neck cancer cells as well as the interactions that Metformin has on the growth or death of tumor cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Metformin 850 mg orally once a day for 3 days, then 850 mg orally twice daily starting day 4 until 24hrs before surgery.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Tumor cell death estimated by percentage
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed HNSCC Stage II-IVB (T1N1-3, T2-3, N0-3, M0) OR Patients with suspected Stage II-IVB tumor as determined by clinical examination or noted via imaging. * Planned complete resection of the primary tumor. * Age \>= 18 years. * ECOG performance status of 0 or 1 * Adequate hepatic, renal, and bone marrow function Exclusion Criteria: * Prior therapy for head and neck cancer * Candidates for neo-adjuvant chemotherapy or chemo-radiation therapy for curative intent. * Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or in situ cervical cancer. * History of diabetes mellitus or taking any medications indicated for diabetes mellitus treatment * Contraindication to metformin including hypersensitivity or allergic reaction * Active diagnosis of Alcoholism * Congestive heart failure requiring pharmacologic treatment. * BMI \< 25 * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breastfeeding women are excluded from this study
References
Publications (3)
- BACKGROUNDFrisch SM, Schaller M, Cieply B. Mechanisms that link the oncogenic epithelial-mesenchymal transition to suppression of anoikis. J Cell Sci. 2013 Jan 1;126(Pt 1):21-9. doi: 10.1242/jcs.120907. PMID 23516327
- BACKGROUNDSandulache VC, Hamblin JS, Skinner HD, Kubik MW, Myers JN, Zevallos JP. Association between metformin use and improved survival in patients with laryngeal squamous cell carcinoma. Head Neck. 2014 Jul;36(7):1039-43. doi: 10.1002/hed.23409. Epub 2014 Jan 29. PMID 23784886
- BACKGROUNDBonanni B, Puntoni M, Cazzaniga M, Pruneri G, Serrano D, Guerrieri-Gonzaga A, Gennari A, Trabacca MS, Galimberti V, Veronesi P, Johansson H, Aristarco V, Bassi F, Luini A, Lazzeroni M, Varricchio C, Viale G, Bruzzi P, Decensi A. Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial. J Clin Oncol. 2012 Jul 20;30(21):2593-600. doi: 10.1200/JCO.2011.39.3769. Epub 2012 May 7. PMID 22564993