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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
First received
Last updated
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
Health authority
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.

Study Design


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
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