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NCT Number: NCT02085460

A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.
  • Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.
  • Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx
  • Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx
  • Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Patients who are able to hold fluid in the mouth
  • Patients who are able to swallow the investigational medicinal product (IMP)
  • Patients expected to survive for at least 3 months
  • Patients who have given written informed consent in person
  • Patients who can stay at or visit the hospital for scheduled examinations and observations
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration

Exclusion criteria

  • Patients with primary malignant tumors other than head and neck cancer.
  • Patients with symptomatic viral, bacterial, or fungal infection
  • Patients with serious renal impairment
  • Patients with distant metastasis
  • Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)
  • Patients with any of the following laboratory test results:
  • Neutrophil count: <1500 L
  • Platelet count: <75000 L
  • Hemoglobin: <10.0 g/L
  • Aspartate aminotransferase (AST): >3 times the upper limit of the reference value at the trial site
  • Alanine aminotransferase (ALT): >3 times the upper limit of the reference value at the trial site
  • Serum bilirubin: >1.5 times the upper limit of the reference value at the trial site
  • Serum albumin: <3.0 g/dL
  • Serum creatinine: >1.5 the upper limit of the reference value at the trial site
  • Creatinine clearance : <30 mL/min
  • Patients complicated with autoimmune disease
  • Patients requiring continuous systemic administration of glucocorticoid
  • Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant
  • Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy
  • Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds
  • Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial

Treatment and study plan

Placebo

Drug

2% Rebamipide liquid

Drug

4% Rebamipide liquid

Drug

Primary outcomes

  1. Incidence of Grade ≥3 Oral Mucositis Determined by Clinical Examination and Assessed by Central Review According to the Common Terminology Criteria of Adverse Events (CTCAE) Version 3.0.

    Time frame: 77 days

    Investigators who had undergone specific training assessed the severity of oral mucositis twice every week. To evaluate the severity of oral mucositis objectively, the clinical findings of the oral mucosa as well as functional disorders and symptomatic aspects were recorded in the Oral Mucositis Assessment Sheet by each investigator. Photographic documentation of the oral mucosa was also submitted by each investigator, 3 days before or 57 days after initiation of chemoradiotherapy, or at the time of withdrawal. The Oral Mucositis Assessment Sheets and photographic documentation were then reviewed by the Oral Mucositis Evaluation Committee to grade the severity of oral mucositis according to the CTCAE 3.0.z

Secondary outcomes

  1. Number of Subjects Who Did Not Developed Grade ≥3 Mucositis

    Time frame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77

    Day 1 was defined as the start of chemotherapy.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2014
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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