NCT05055726

Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

Phase IV Study on the Feasibility of a Preventative/Therapeutic Approach With Benzydamine Oromucosal Solution in Radiation-induced Oral Mucositis (OM) in Patients With Head and Neck Cancer (HNC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with head and neck cancer.

Detailed description

This is a phase IV clinical study whose aim is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with Head and Neck cancer. Benzydamine mouthwash is considered the gold standard among anti-inflammatory agents in the management of oral mucositis in cancer patients. The 2014 mucositis guidelines recommended benzydamine mouthwash for the prevention of radiation-induced oral mucositis among Head and Neck Cancer patients treated with moderate doses of radiation therapy. The updated 2019 guidelines not only confirm the existing guidelines proving new evidences, but also recommend to use benzydamine as preventative treatment of radiation-induced Oromucositi among Head and Neck Cancer. patients treated with radiation therapy with/without systemic concurrent treatments and confirm benzydamine mouthwash as the only anti-inflammatory agent with evidence in prevention of oral mucositis to date.

Conditions

• Radiation-Induced Mucositis
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Benzydamine Hydrochloride 0.15% w/v oromucosal solution	Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-09-05
• Completion: 2022-09-05
• First posted: 2021-09-24
• Last updated: 2022-11-16

Locations

10 sites across 2 countries: Hungary, Poland