18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and RadiationPrimary· 24 months
Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.
Group
Value
95% CI
Metformin (2000mg) With Chemoradiation
NA
Metformin (2550mg) With Chemoradiation
NA
Metformin (3000mg) With Chemoradiation
NA
Number of Participants Experiencing No-Reoccurrence at 36 MonthsSecondary· 36 months
Patients were evaulated at 36 months to determine if there was recurrence of disease.
Group
Value
95% CI
Metformin (2000mg) With Chemoradiation
6
Metformin (2550mg) With Chemoradiation
8
Metformin (3000mg) With Chemoradiation
4
Number of Participants With Adverse EventsSecondary· 36 months
Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.Any participants with any adverse event at any grade was included. Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
Group
Value
95% CI
Metformin (2000mg) With Chemoradiation
6
Metformin (2550mg) With Chemoradiation
7
Metformin (3000mg) With Chemoradiation
4
Progression Free SurvivalSecondary· 24 months
2-year progression free survival
Group
Value
95% CI
Metformin (2000mg) With Chemoradiation
6
Metformin (2550mg) With Chemoradiation
8
Metformin (3000mg) With Chemoradiation
4
Overall SurvivalSecondary· 24 months
2 year overall survival
Group
Value
95% CI
Metformin (2000mg) With Chemoradiation
5
Metformin (2550mg) With Chemoradiation
8
Metformin (3000mg) With Chemoradiation
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks.
Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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 University of Cincinnati trials
Trials by the same sponsor.
NCT05605366 — Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
· Phase 1
· not yet recruiting
NCT07528638 — Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
· NA
· not yet recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment
· NA
· recruiting
NCT07447895 — Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
· NA
· not yet recruiting
NCT07231588 — Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
· EARLY_PHASE1
· recruiting
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 University of Cincinnati
Last refreshed: 11 June 2020
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/NCT02325401.