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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03109873
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : November 20, 2019
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Larynx Lip Oral Cavity Pharynx Radiation: External Beam Radiation Therapy Drug: Metformin Hydrochloride Other: Placebo Early Phase 1

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Metformin in Head and Neck Cancer and Its Effect on Proinflammatory Cytokines and Exosomes Implicated in Acute and Chronic Toxicity
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (EBRT, metformin hydrochloride)
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
Undergo External Beam Radiation Therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT

Drug: Metformin Hydrochloride
Given orally
Other Names:
  • 1,1-Dimethylbiguanide Hydrochloride
  • 1115-70-4
  • 91485
  • Cidophage
  • Glucoformin
  • Glucophage ER
  • Dimefor
Placebo Comparator: Arm II (EBRT, placebo)
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
Undergo External Beam Radiation Therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT

Other: Placebo
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. Cytokine/Chemokine Profile [ Time Frame: Up to 1 year ]
    Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.


Secondary Outcome Measures :
  1. Mucositis Assessed Using WHO Classification [ Time Frame: Up to 1 year ]
    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.

  2. Objective Response Rate [ Time Frame: Up to 2 years ]
    The objective response rate will be estimated by arm along with an exact 95% binomial confidence interval

  3. Exosome Profile [ Time Frame: Up to 1 year ]
    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.

  4. Incidence of Toxicities [ Time Frame: Up to 2 years ]
    Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109873


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Adam Luginbuhl, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Study Protocol and Statistical Analysis Plan  [PDF] June 20, 2019

More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03109873    
Other Study ID Numbers: 16D.639
First Posted: April 12, 2017    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: December 29, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs