Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

NCT05055726 | Completed Phase 4

• 2 other identifiers: 030(Z)WO192472020-003306-32
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Radiation-Induced Mucositis; Head and Neck Cancer

Keywords

oral mucositis; radiation therapy; head and neck cancer; mouthwash; oromucosal solution; benzydamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Number of compliant patients to Benzydamine treatment.

  Up to 7 weeks

• Change score in the World Health Organization oral mucositis grading scale.

  Up to 7 weeks

• Number of days of duration of severe oral mucositis.

  Up to 7 weeks

• Time of onset of severe oral mucositis.

  Up to 7 weeks

• Percentage change in body weight

  Up to 7 weeks

Study Arms (1)

Benzydamine Hydrochloride 0.15% w/v oromucosal solution

EXPERIMENTAL

Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A., is assigned to the patients for radiation-induced oromucositis. The patients take at home 15 ml (1 tablespoon) of concentrated or diluted (with water) mouthwash 2-3 times a day, but not more than 5 times a day, washing the mouth and throat for 20-30 seconds, according to the Investigator's indications and the local product's SmPC. In Hungary, the therapy should started with diluted product (15 ml of water + 15 ml of concentrated solution). After that, gargling can be continued with 15 ml (1 tablespoon) of concentrated mouthwash, generally 2-3 times a day, but not more than 5 times a day. In Poland, the solution is used 2 to 3 times daily; at a single time, it should be used approximately 15 ml of concentrated or diluted mouthwash with a small amount of water and wash the mouth and throat for 20 to 30 seconds.

Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Interventions

Benzydamine Hydrochloride 0.15% w/v oromucosal solution DRUG

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

Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• PPD Development, LP: collaborator

Study Sites (10)

Orszagos Onkologiai Intezet, Gyogyszertar

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar

Debrecen, 4032, Hungary

Location

Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,

Győr, 9024, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.

Kaposvár, 7400, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly

Nyíregyháza, 4400, Hungary

Location

Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly

Veszprém, 8200, Hungary

Location

Centrum Onkologii im. Prof. Franciszka Łukaszczyka Apteka Szpitalna

Bydgoszcz, 85-796, Poland

Location

Szpitale Pomorskie Sp. z o. o.,

Gdynia, 81-519, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie

Lodz, 95-513, Poland

Location

Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach -

Siedlce, 08-110, Poland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Interventions

Benzydamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, international, open label, single-group study

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: September 24, 2021
• Study Start: December 6, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

PL (4); HU (6)