NCT03109873

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

Pilot Study of Metformin in Head and Neck Cancer and Its Effect on Proinflammatory Cytokines and Exosomes Implicated in Acute and Chronic Toxicity

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the capacity of metformin hydrochloride (metformin) to alter the cytokine and exosome profiles. II. To assess the capacity of metformin to mitigate known side effects of external beam radiation therapy including inflammation, mucositis, dysphagia, xerostomia, and fatigue. SECONDARY OBJECTIVES: I. Assess safety and tolerability of metformin treatment in subjects undergoing external beam radiation treatment for head and neck cancer. II. To determine the effect of metformin treatment on symptoms of xerostomia as assessed by the Xerostomia Questionnaire (XQ). III. To determine the effect of metformin treatment on symptoms of mucositis as assessed by World Health Organization (WHO) classification. IV. To determine the effect of metformin treatment on symptoms of dysphagia as assessed by the MD Anderson Dysphagia Inventory. V. To determine the effect of metformin treatment on symptoms of fatigue as assess by the Multidimensional Fatigue Inventory (MFI).

Conditions

• Larynx
• Lip
• Oral Cavity
• Pharynx

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo External Beam Radiation Therapy
DRUG	Metformin Hydrochloride	Given orally
OTHER	Placebo	Given orally

Timeline

• Start date: 2017-01-05
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2017-04-12
• Last updated: 2025-04-30
• Results posted: 2019-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study