NCT03510390 (HEAD-MET) is a NA clinical trial of Metformin in Head and Neck Cancer, sponsored by Insel Gruppe AG, University Hospital Bern.

Who is sponsoring NCT03510390?

NCT03510390 is sponsored by Insel Gruppe AG, University Hospital Bern.

What drugs are being tested in NCT03510390?

Interventions in NCT03510390: Metformin.

What condition does NCT03510390 study?

NCT03510390 studies Head and Neck Cancer, Oral Cavity Squamous Cell Carcinoma.

Is NCT03510390 still recruiting?

NCT03510390 is currently completed. Last updated 18 November 2021.

Last reviewed 2021-11-18 · How we verify

NCT03510390: HEAD-MET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Metformin in Head and Neck Squamous Cell Carcinoma: Effect on Tissue Oxygenation

Completed NA Last updated 18 November 2021

What this trial tests

NA trial testing Metformin in Head and Neck Cancer in 17 participants. Completed in 15 November 2021.

Timeline

13 June 2018

Primary endpoint
15 September 2021

15 November 2021

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	17
Start date	13 June 2018
Primary completion	15 September 2021
Estimated completion	15 November 2021
Sites	1 location across Switzerland

Drugs / interventions tested

Metformin (metformin) — full drug profile →

Conditions studied

Head and Neck Cancer — all drugs for Head and Neck Cancer →
Oral Cavity Squamous Cell Carcinoma — all drugs for Oral Cavity Squamous Cell Carcinoma →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Head and Neck Cancer or Oral Cavity Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study evaluates the effects of the drug Metformin on the oxygen content in cancer tissue. Low oxygen concentration in cancer tissue accelerates cancer growth. Moreover, the response to radiation therapy is worse when tissue oxygen is low, because radiation therapy depends on oxygen to unfold therapeutic effects. Metformin has been used to treat type II diabetes for over 50 years and features additional properties that could slow down cancer growth. One of these properties is the improved oxygen concentration in cancer tissue. This effect has been proven for various cancers. This study was planned to verify this effect in head and neck cancer. Patients who suffer from cancer of the mouth and are planned for surgical removal of the cancer will be given Metformin for 9 to 14 days. The tissue removed in the subsequent surgery will be compared to a tissue sample that had been taken from the same patient prior to Metformin intake. To evaluate the oxygen content in the tissue samples, the expression of genes that react to oxygen levels will be measured and compared between the samples taken before and after treatment with Metformin. A secondary aim is to evaluate whether changes in the oxygen content within the tumor can be visualized by means of magnetic resonance imaging (MRI). Therefore, participants undergo an MRI scan, before and after Treatment with Metformin. The changes in the MRI will be correlated to the changes measured in gene expression.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Tumor Microenvironment for Cancer Therapy.
Roma-Rodrigues C, Mendes R, Baptista PV, Fernandes AR. · · 2019 · cited 865× · PMID 30781344 · DOI 10.3390/ijms20040840
Tumor microenvironment: barrier or opportunity towards effective cancer therapy.
Tiwari A, Trivedi R, Lin SY. · · 2022 · cited 257× · PMID 36253762 · DOI 10.1186/s12929-022-00866-3
Targeting AKT/mTOR in Oral Cancer: Mechanisms and Advances in Clinical Trials.
Harsha C, Banik K, Ang HL, Girisa S, et al · · 2020 · cited 152× · PMID 32384682 · DOI 10.3390/ijms21093285
Adaptive Mechanisms of Tumor Therapy Resistance Driven by Tumor Microenvironment.
Wu P, Gao W, Su M, Nice EC, et al · · 2021 · cited 136× · PMID 33732706 · DOI 10.3389/fcell.2021.641469
Tumor hypoxia: From basic knowledge to therapeutic implications.
Liao C, Liu X, Zhang C, Zhang Q. · · 2023 · cited 123× · PMID 36603793 · DOI 10.1016/j.semcancer.2022.12.011
Interfering with Tumor Hypoxia for Radiotherapy Optimization.
Telarovic I, Wenger RH, Pruschy M. · · 2021 · cited 119× · PMID 34154610 · DOI 10.1186/s13046-021-02000-x
Metabolic requirements of pulmonary fibrosis: role of fibroblast metabolism.
Hamanaka RB, Mutlu GM. · · 2021 · cited 69× · PMID 33393204 · DOI 10.1111/febs.15693
Immunometabolism: new insights and lessons from antigen-directed cellular immune responses.
Ramalho R, Rao M, Zhang C, Agrati C, et al · · 2020 · cited 39× · PMID 32519148 · DOI 10.1007/s00281-020-00798-w

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients · NA · recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde · Phase 3 · recruiting
NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema · NA · recruiting

Other Insel Gruppe AG, University Hospital Bern trials

Trials by the same sponsor.

NCT06546384 — GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease · NA · not yet recruiting
NCT07524049 — Giving Children a Voice in Paediatric Anaesthesia · not yet recruiting
NCT07415668 — Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning · NA · not yet recruiting
NCT07478536 — Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial) · not yet recruiting
NCT07201506 — Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03510390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
Last refreshed: 18 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03510390.

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