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

NCT ID: NCT02085460

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

6 times daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2% Rebamipide liquid

6 times daily

Group Type: EXPERIMENTAL

2% Rebamipide liquid

Intervention Type: DRUG

4% Rebamipide liquid

6 times daily

Group Type: EXPERIMENTAL

4% Rebamipide liquid

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

2% Rebamipide liquid

Intervention Type: DRUG

4% Rebamipide liquid

Intervention Type: DRUG

Eligibility Criteria

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.

1. Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx

2. 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:

1. Neutrophil count: <1500 L

2. Platelet count: <75000 L

3. Hemoglobin: <10.0 g/L

4. Aspartate aminotransferase (AST): >3 times the upper limit of the reference value at the trial site

5. Alanine aminotransferase (ALT): >3 times the upper limit of the reference value at the trial site

6. Serum bilirubin: >1.5 times the upper limit of the reference value at the trial site

7. Serum albumin: <3.0 g/dL

8. Serum creatinine: >1.5 the upper limit of the reference value at the trial site

9. 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun-ichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Tohoku Region, , Japan

Countries

Japan

References

Ueno T, Zenda S, Konishi T, Yurikusa T, Shibasaki Y, Nagamoto H, Fujii M. The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer. Int J Clin Oncol. 2019 Mar;24(3):241-247. doi: 10.1007/s10147-018-1355-7. Epub 2018 Nov 13.

Reference Type: BACKGROUND

PMID: 30426268 (View on PubMed)

Yokota T, Ogawa T, Takahashi S, Okami K, Fujii T, Tanaka K, Iwae S, Ota I, Ueda T, Monden N, Matsuura K, Kojima H, Ueda S, Sasaki K, Fujimoto Y, Hasegawa Y, Beppu T, Nishimori H, Hirano S, Naka Y, Matsushima Y, Fujii M, Tahara M. Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study. BMC Cancer. 2017 May 5;17(1):314. doi: 10.1186/s12885-017-3295-4.

Reference Type: DERIVED

PMID: 28476132 (View on PubMed)

Other Identifiers

JapicCTI-142467

Identifier Type: OTHER

Identifier Source: secondary_id

037-12-001

Identifier Type: -

Identifier Source: org_study_id