Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Subjects will sign informed consent and have their medical records reviewed, a physical exam and blood taken for lab tests and a biopsy of the cancer will be taken to determine eligibility for the study.

Following enrollment, the subject will begin to take Metformin at a dosage of 850 mg daily on Days 1 through 3 (in the mornings with breakfast). On day 3 the study team will call to see if the subject is tolerating the Metformin.

If tolerated, then the dose will increase to 850 mg twice a day (with breakfast and dinner) on starting on Day 4.

This dose is to continue until 24 hours prior to surgery, with a minimum of 14 days but can be extended until 28 days dependent on planned surgery date.

The study team will provide the subject with the Metformin and a study diary to record when they take their pills and if there are any issues to communicate to the physician. They will also be contacted by phone or planned visit days to see how their body is tolerating the Metformin throughout their treatment (approximately every 3 days).

On Day 14 plus or minus 3 days (or 2 weeks after staring Metformin) and immediately prior to surgery, the physician will collect a blood sample.

On the day of surgery, the surgeon will remove the tumor and send it to the lab for evaluation as part of standard cancer care. They will also collect an additional biopsy of the tumor for research purposes to test the effects of Metformin on the tumor cells.

The subjects will be followed for 30 days after their surgery.

The blood and tumor samples collected will be sent to a research lab at WVU for to test the effect of Metformin, tumor genotype and Metformin genotype interactions on critical tumor cell metabolic parameters and also on anoikis-sensitivity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02402348
Study type	Interventional
Source	West Virginia University
Contact
Status	Terminated
Phase	Early Phase 1
Start date	December 2014
Completion date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT05331131` - Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial	Phase 2
Completed	`NCT05269342` - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer	N/A
Completed	`NCT03574870` - Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer	N/A
Recruiting	`NCT04804852` - Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer
Active, not recruiting	`NCT04617678` - A Comprehensive Approach to Head and Neck Cancer Prehabilitation	N/A
Completed	`NCT03419741` - Brain Stimulation For Cancer Smokers	N/A
Recruiting	`NCT02528955` - De-Intensification Radiotherapy Postoperative Head Neck	Phase 2
Completed	`NCT00318890` - Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck	Phase 1/Phase 2
Recruiting	`NCT05179824` - Tempus Priority Study: A Pan-tumor Observational Study
Recruiting	`NCT05316974` - Lymphoedema Among Persons With Head- and Neck Cancer
Not yet recruiting	`NCT03954691` - Targeting Potassium Channels to Reprogram Glioblastoma Microenvironment: in Vitro and in Vivo Studies
Active, not recruiting	`NCT03760471` - Palliative and Oncology Care Intervention: Symptom COACH	N/A
Completed	`NCT04554667` - Heavy Lifting Strength Training in Head and Neck Cancer Survivors	Phase 1
Completed	`NCT02869399` - Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention	N/A
Completed	`NCT02366611` - Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer	N/A
Completed	`NCT02075112` - Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck	Phase 1
Completed	`NCT00798655` - Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer	Phase 2
Completed	`NCT02900911` - Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy	N/A
Completed	`NCT01317589` - Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective?	Phase 4
Completed	`NCT03841175` - Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms