NCT02402348

Brief Summary

The study researchers want to look at the overall effects that Metformin may have on the tumor characteristics of Head and Neck cancer cells as well as the interactions that Metformin has on the growth or death of tumor cells.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

March 24, 2015

Last Update Submit

February 6, 2017

Conditions

Cancer of Head and Neck

Keywords

head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Tumor cell death estimated by percentage

    30 days

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin 850 mg orally once a day for 3 days, then 850 mg orally twice daily starting day 4 until 24hrs before surgery.

Drug: Metformin

Interventions

MetforminDRUG
Also known as: Glucophage
Metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed HNSCC Stage II-IVB (T1N1-3, T2-3, N0-3, M0) OR Patients with suspected Stage II-IVB tumor as determined by clinical examination or noted via imaging.
  • Planned complete resection of the primary tumor.
  • Age \>= 18 years.
  • ECOG performance status of 0 or 1
  • Adequate hepatic, renal, and bone marrow function

You may not qualify if:

  • Prior therapy for head and neck cancer
  • Candidates for neo-adjuvant chemotherapy or chemo-radiation therapy for curative intent.
  • Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or in situ cervical cancer.
  • History of diabetes mellitus or taking any medications indicated for diabetes mellitus treatment
  • Contraindication to metformin including hypersensitivity or allergic reaction
  • Active diagnosis of Alcoholism
  • Congestive heart failure requiring pharmacologic treatment.
  • BMI \< 25
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breastfeeding women are excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Hospitals - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (3)

  • Frisch SM, Schaller M, Cieply B. Mechanisms that link the oncogenic epithelial-mesenchymal transition to suppression of anoikis. J Cell Sci. 2013 Jan 1;126(Pt 1):21-9. doi: 10.1242/jcs.120907.

    PMID: 23516327BACKGROUND

  • Sandulache VC, Hamblin JS, Skinner HD, Kubik MW, Myers JN, Zevallos JP. Association between metformin use and improved survival in patients with laryngeal squamous cell carcinoma. Head Neck. 2014 Jul;36(7):1039-43. doi: 10.1002/hed.23409. Epub 2014 Jan 29.

    PMID: 23784886BACKGROUND

  • Bonanni B, Puntoni M, Cazzaniga M, Pruneri G, Serrano D, Guerrieri-Gonzaga A, Gennari A, Trabacca MS, Galimberti V, Veronesi P, Johansson H, Aristarco V, Bassi F, Luini A, Lazzeroni M, Varricchio C, Viale G, Bruzzi P, Decensi A. Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial. J Clin Oncol. 2012 Jul 20;30(21):2593-600. doi: 10.1200/JCO.2011.39.3769. Epub 2012 May 7.

    PMID: 22564993BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Tanya Fancy, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 30, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)