Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer

NCT03109873 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 16D.639JT 9410
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well metformin hydrochloride works in affecting cytokines and exosomes in patients with head and neck cancer. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissues.

Conditions

Larynx; Lip; Oral Cavity; Pharynx

Outcome Measures

Primary Outcomes (1)

• Cytokine/Chemokine Profile

  Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.

  Up to 1 year

Secondary Outcomes (4)

• Mucositis Assessed Using WHO Classification

  Up to 1 year

• Objective Response Rate

  Up to 2 years

• Exosome Profile

  Up to 1 year

• Incidence of Toxicities

  Up to 2 years

Study Arms (2)

Arm I (EBRT, metformin hydrochloride)

EXPERIMENTAL

Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.

Radiation: External Beam Radiation Therapy; Drug: Metformin Hydrochloride

Arm II (EBRT, placebo)

PLACEBO COMPARATOR

Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.

Radiation: External Beam Radiation Therapy; Other: Placebo

Interventions

External Beam Radiation Therapy RADIATION

Undergo External Beam Radiation Therapy

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT

Arm I (EBRT, metformin hydrochloride); Arm II (EBRT, placebo)

Metformin Hydrochloride DRUG

Given orally

Also known as: 1,1-Dimethylbiguanide Hydrochloride, 1115-70-4, 91485, Cidophage, Glucoformin, Glucophage ER, Dimefor

Arm I (EBRT, metformin hydrochloride)

Placebo OTHER

Given orally

Arm II (EBRT, placebo)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a diagnosis of head and neck cancer biopsy proven, and who are candidates for radiation therapy
• All subjects must be able to comprehend and sign a written informed consent document.

You may not qualify if:

• Subjects who are pregnant or may become pregnant during metformin administration; pregnancy testing will be done in conjunction with preradiation protocols
• Subjects on metformin for any reason during the preceding 4 weeks
• Diabetic subjects are eligible if they are not taking metformin or insulin
• Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
• Patients with plasma creatinine level greater than 1.3 mg/dL
• Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
• Patients with history of congestive heart failure
• Patients with myocardial ischemia or peripheral muscle ischemia
• Patients with sepsis or severe infection
• Patients with history of lung disease currently requiring any supplemental oxygen treatment
• Patients scheduled for radiation less than 6 days from enrollment
• Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
• Patients with a current history (in the past 30 days) of heaving drinking which is defined in accordance with CDC definition as more than 8 drinks per week for women and more than 15 drinks per week for men. A standard drink contains .6 ounces of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than 8 drinks per week for women and no more than 15 drinks per week for men. Patients who feel they cannot comply with this recommendation are not eligible".
• All medications are permitted except those that are contraindicated with metformin under current Food and Drug Administration (FDA) recommendations

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Laryngeal Diseases; Lymphoid Interstitial Pneumonia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Adam Luginbuhl
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

adam.luginbuhl@jefferson.ed

215-240-0748

Study Officials

• Adam Luginbuhl, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 12, 2017
• Study Start: January 5, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 30, 2025
• Results First Posted: November 20, 2019

Record last verified: 2025-04

Locations

US (1)