Clinical trial NCT05055726: Benzydamine Oromucosal Solution in Oral Mucositis (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiation-Induced Mucositis
Head and Neck Cancer
Keywords: oral mucositis
radiation therapy
head and neck cancer
mouthwash
oromucosal solution
benzydamine
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2021-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multicenter, international, open label, single-group study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of responders
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Number of compliant patients to Benzydamine treatment.
timeFrame: Up to 7 weeks
measure: Change score in the World Health Organization oral mucositis grading scale.
timeFrame: Up to 7 weeks
measure: Number of days of duration of severe oral mucositis.
timeFrame: Up to 7 weeks
measure: Time of onset of severe oral mucositis.
timeFrame: Up to 7 weeks
measure: Percentage change in body weight
timeFrame: Up to 7 weeks
measure: Number of days of duration of Radiotherapy/Chemotherapy
timeFrame: Up to 7 weeks
measure: Number of days of discontinuation of Radiotherapy/Chemotherapy
timeFrame: Up to 7 weeks
measure: Dose modifications of Radiotherapy/Chemotherapy
timeFrame: Up to 7 weeks
measure: Delays in Radiotherapy/Chemotherapy
timeFrame: Up to 7 weeks
measure: Number of days of hospitalization.
timeFrame: Up to 7 weeks
measure: Change in QoL (EORTC QLQ C-30) from baseline
timeFrame: Up to 7 weeks
measure: Change in QoL (EORTC QLQ-H&N35) from baseline
timeFrame: Up to 7 weeks
measure: Number and type of opioid analgesics
timeFrame: Up to 7 weeks
measure: Frequency of adverse events
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, Gyogyszertar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar
city: Győr
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka Apteka Szpitalna
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.,
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach -
city: Łódź
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie
Study officials:
References: