Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

Head and Neck Cancer Clinical Trial

— BOOM  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055726
• Other study ID #: 030(Z)WO19247
• Secondary ID: 2020-003306-32
• Status: Completed
• Phase: Phase 4
• Start date: December 6, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: November 2022
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients of any ethnic origin =18 years of age.
• Patients diagnosed with stage III or IV Head and Neck cancer (histologic or cytologic diagnosis), according to VIII AJCC staging system, who are candidate and are about to start RT, with or without concomitant CT, with curative intent, either with exclusive or postoperative intent.
• Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
• Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent and the Declaration of consent for the processing of personal data.
• Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the end of the study, using an appropriate birth control method, such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions

will be considered:

• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

Exclusion Criteria:

• Patients with reported allergy to benzydamine or another component of the formulation used.
• Any contraindications listed in the local product's Summary of Product Characteristics (SmPCs).
• Patients with prior head and neck RT (in the previous 6 months), or patient who received a palliative treatment.
• Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions.
• Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.).
• Patients who use other oromucosal products (over the counter or prescription) for the same disease.
• Prescription of other rinses (anaesthetics like "magic mouthwashes" or others), except from sodium bicarbonate rinses.
• Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol, granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel.
• Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; any therapeutic use in case of overt clinical infections is allowed.
• Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition.
• Patients treated with any topical anti-inflammatory/analgesic products for the mucositis.
• Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator's assessment.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Radiation-Induced Mucositis
• Stomatitis

Intervention

Drug:
• Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.

Locations

Country	Name	City	State
Hungary	Orszagos Onkologiai Intezet, Gyogyszertar	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar	Debrecen
Hungary	Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,	Gyor
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.	Kaposvár
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly	Nyíregyháza
Hungary	Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly	Veszprém
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka Apteka Szpitalna	Bydgoszcz
Poland	Szpitale Pomorskie Sp. z o. o.,	Gdynia
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie	Lódz
Poland	Mazowiecki Szpital Wojewódzki im. sw. Jana Pawla II w Siedlcach -	Siedlce

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	PPD

Countries where clinical trial is conducted

Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of responders	The effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/tratment of radiation-induced oral mucositis in Head and Neck cancer patients is evaluated as the number of responders, expressed in percentage, defined as the number of head and neck cancer patients with oral mucositis pain intensity <5 in the Numeric Rating Scale.	Up to 7 weeks
Secondary	Number of compliant patients to Benzydamine treatment.	The compliance to the treatment is calculated at the end of the study. A patient is considered compliant to the benzydamine treatment if he/she takes =80% of the total dose assigned by the Investigator.	Up to 7 weeks
Secondary	Change score in the World Health Organization oral mucositis grading scale.	The severity of oral mucositis is evaluated using the World Health Organization (WHO) oral mucositis grading scale.; The Investigator gives a score corresponding to the grade of mucositis of the patient, from "0" = "None" to "4" = "Life-threatening", "Oral alimentation impossible".	Up to 7 weeks
Secondary	Number of days of duration of severe oral mucositis.	The duration of severe oral mucositis (grade 3 or 4 on the World Health Organization oral mucositis grading scale) is assessed.	Up to 7 weeks
Secondary	Time of onset of severe oral mucositis.	Time of onset of severe oral mucositis (grade 3 or 4 on the World Health Organization oral mucositis grading scale) is assessed.	Up to 7 weeks
Secondary	Percentage change in body weight	The percentage change in body weight from baseline is assessed.	Up to 7 weeks
Secondary	Number of days of duration of Radiotherapy/Chemotherapy	Radiotherapy/Chemotherapy is assessed as number of days of duration of therapy.	Up to 7 weeks
Secondary	Number of days of discontinuation of Radiotherapy/Chemotherapy	Radiotherapy/Chemotherapy is assessed in terms of days of therapy discontinuation.	Up to 7 weeks
Secondary	Dose modifications of Radiotherapy/Chemotherapy	Radiotherapy/Chemotherapy is evaluated as dose modifications of therapy.	Up to 7 weeks
Secondary	Delays in Radiotherapy/Chemotherapy	Radiotherapy/Chemotherapy is evaluated as days of delay in therapy.	Up to 7 weeks
Secondary	Number of days of hospitalization.	The healthcare resources consumed in terms of number of days of hospitalization due to oral mucositis are evaluated.	Up to 7 weeks
Secondary	Change in QoL (EORTC QLQ C-30) from baseline	The health-related quality of life is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)	Up to 7 weeks
Secondary	Change in QoL (EORTC QLQ-H&N35) from baseline	The health-related quality of life is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck (EORTC QLQ-H&N35).	Up to 7 weeks
Secondary	Number and type of opioid analgesics	The use of opioid analgesics prescribed for oral mucositis pain is assessed.	Up to 7 weeks
Secondary	Frequency of adverse events	AEs occurred during a clinical trial are assessed by the Investigator in terms of seriousness and relationship with the investigational product.	Up to 7 weeks