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NCT03109873 · OUTCOME

Mucositis Assessed Using WHO Classification

Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer · Source last updated 2025-04-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

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.

Analysis population: Due to insufficient accrual, statistical results cannot be reported.

Groups in this outcome

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. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Metformin Hydrochloride: Given orally

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. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Placebo: Given orally

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (EBRT, Metformin Hydrochloride)0
Arm II (EBRT, Placebo)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
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.
groups
  1. 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. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Metformin Hydrochloride: Given orally
    id
    OG000
    title
    Arm I (EBRT, Metformin Hydrochloride)
  2. 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. External Beam Radiation Therapy: Undergo External Beam Radiation Therapy Placebo: Given orally
    id
    OG001
    title
    Arm II (EBRT, Placebo)
population Description
Due to insufficient accrual, statistical results cannot be reported.
reporting Status
POSTED
time Frame
Up to 1 year
title
Mucositis Assessed Using WHO Classification
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice