A Multinational, Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial to Determine the Efficacy and Safety of IB-367 Rinse in Reducing the Severity of Oral Mucositis in Patients Receiving Radiotherapy for Head and Neck Malignancy
OBJECTIVES: I. Compare the efficacy and safety of iseganan HCl oral solution vs placebo in
patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. II.
Compare the effects of these treatments on mouth pain, ability to swallow, weight loss, and
the distribution of oral mucositis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to radiotherapy (conventional fractionating radiotherapy vs
hyperfractionating or concurrent boost radiotherapy) and concurrent chemotherapy (yes vs
no). Patients are randomized to 1 of 3 arms. Arm I: Patients rinse with iseganan HCl oral
solution 6 times daily. Treatment continues for the duration of the scheduled radiotherapy.
Arm II: Patients rinse with oral placebo 6 times daily. Treatment continues for the duration
of the scheduled radiotherapy. Arm III: Patients receive standard-of-care supportive
treatment. Oral cavity pain, ability to swallow, and weight loss are assessed twice weekly
and on follow-up days 28 and 56. Patients are followed on days 28 and 56.
PROJECTED ACCRUAL: A total of 504 patients (252 for arm I, 168 for arm II, and 84 for arm
III) will be accrued for this study.
Primary Purpose: Supportive Care
Guy J. F. Juillard, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|