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

NCT03109873 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-04-30

Study results available
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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

Interventions

RADIATION

External Beam Radiation Therapy

Undergo External Beam Radiation Therapy

DRUG

Metformin Hydrochloride

Given orally

OTHER

Placebo

Given orally

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Adam Luginbuhl, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109873 on ClinicalTrials.gov