NCT03109873 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: EARLY PHASE1
Status at capture: COMPLETED
Registry last update: 2025-04-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Cytokine/Chemokine Profile

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outcome · POSTED

Mucositis Assessed Using WHO Classification

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Exosome Profile

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outcome · POSTED

Incidence of Toxicities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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. Exclusion Criteria: * 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
healthy Volunteers: false
maximum Age: 90 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Radiation: External Beam Radiation Therapy
Drug: Metformin Hydrochloride
label
Arm I (EBRT, metformin hydrochloride)
type
EXPERIMENTAL
description
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.
intervention Names
Radiation: External Beam Radiation Therapy
Other: Placebo
label
Arm II (EBRT, placebo)
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I (EBRT, metformin hydrochloride)
Arm II (EBRT, placebo)
description
Undergo External Beam Radiation Therapy
name
External Beam Radiation Therapy
other Names
Definitive Radiation Therapy
EBRT
External Beam RT
type
RADIATION
arm Group Labels
Arm I (EBRT, metformin hydrochloride)
description
Given orally
name
Metformin Hydrochloride
other Names
1,1-Dimethylbiguanide Hydrochloride
1115-70-4
91485
Cidophage
Glucoformin
Glucophage ER
Dimefor
type
DRUG
arm Group Labels
Arm II (EBRT, placebo)
description
Given orally
name
Placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.
measure
Cytokine/Chemokine Profile
time Frame
Up to 1 year

secondary Outcomes

description
Analysis will be primarily descriptive. The distribution of swallowing function and mucositis scores will be summarized by arm using means, medians, standard deviations, and ranges.
measure
Mucositis Assessed Using WHO Classification
time Frame
Up to 1 year
description
The objective response rate will be estimated by arm along with an exact 95% binomial confidence interval
measure
Objective Response Rate
time Frame
Up to 2 years
description
Longitudinal measurements of exosomes will also be modeled using mixed effects linear regression. This analysis is treated as separate from the cytokine questions and the p-value will not be adjusted.
measure
Exosome Profile
time Frame
Up to 1 year
description
Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
measure
Incidence of Toxicities
time Frame
Up to 2 years

Full study description

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.
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).

Source references