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Benzydamine Oromucosal Solution in Oral Mucositis (BOOM) (BOOM)

Primary Purpose

Radiation-Induced Mucositis, Head and Neck Cancer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Sponsored by
Aziende Chimiche Riunite Angelini Francesco S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation-Induced Mucositis focused on measuring oral mucositis, radiation therapy, head and neck cancer, mouthwash, oromucosal solution, benzydamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orszagos Onkologiai Intezet, Gyogyszertar
  • Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar
  • Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,
  • Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly
  • Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly
  • Centrum Onkologii im. Prof. Franciszka Łukaszczyka Apteka Szpitalna
  • Szpitale Pomorskie Sp. z o. o.,
  • Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach -
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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".
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.
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.
Percentage change in body weight
The percentage change in body weight from baseline is assessed.
Number of days of duration of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is assessed as number of days of duration of therapy.
Number of days of discontinuation of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is assessed in terms of days of therapy discontinuation.
Dose modifications of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is evaluated as dose modifications of therapy.
Delays in Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is evaluated as days of delay in therapy.
Number of days of hospitalization.
The healthcare resources consumed in terms of number of days of hospitalization due to oral mucositis are evaluated.
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)
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).
Number and type of opioid analgesics
The use of opioid analgesics prescribed for oral mucositis pain is assessed.
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.

Full Information

First Posted
June 23, 2021
Last Updated
November 15, 2022
Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT05055726
Brief Title
Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)
Acronym
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-Induced Mucositis, Head and Neck Cancer
Keywords
oral mucositis, radiation therapy, head and neck cancer, mouthwash, oromucosal solution, benzydamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
multicenter, international, open label, single-group study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Intervention Description
Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.
Primary Outcome Measure Information:
Title
Number of responders
Description
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.
Time Frame
Up to 7 weeks
Secondary Outcome Measure Information:
Title
Number of compliant patients to Benzydamine treatment.
Description
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.
Time Frame
Up to 7 weeks
Title
Change score in the World Health Organization oral mucositis grading scale.
Description
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".
Time Frame
Up to 7 weeks
Title
Number of days of duration of severe oral mucositis.
Description
The duration of severe oral mucositis (grade 3 or 4 on the World Health Organization oral mucositis grading scale) is assessed.
Time Frame
Up to 7 weeks
Title
Time of onset of severe oral mucositis.
Description
Time of onset of severe oral mucositis (grade 3 or 4 on the World Health Organization oral mucositis grading scale) is assessed.
Time Frame
Up to 7 weeks
Title
Percentage change in body weight
Description
The percentage change in body weight from baseline is assessed.
Time Frame
Up to 7 weeks
Title
Number of days of duration of Radiotherapy/Chemotherapy
Description
Radiotherapy/Chemotherapy is assessed as number of days of duration of therapy.
Time Frame
Up to 7 weeks
Title
Number of days of discontinuation of Radiotherapy/Chemotherapy
Description
Radiotherapy/Chemotherapy is assessed in terms of days of therapy discontinuation.
Time Frame
Up to 7 weeks
Title
Dose modifications of Radiotherapy/Chemotherapy
Description
Radiotherapy/Chemotherapy is evaluated as dose modifications of therapy.
Time Frame
Up to 7 weeks
Title
Delays in Radiotherapy/Chemotherapy
Description
Radiotherapy/Chemotherapy is evaluated as days of delay in therapy.
Time Frame
Up to 7 weeks
Title
Number of days of hospitalization.
Description
The healthcare resources consumed in terms of number of days of hospitalization due to oral mucositis are evaluated.
Time Frame
Up to 7 weeks
Title
Change in QoL (EORTC QLQ C-30) from baseline
Description
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)
Time Frame
Up to 7 weeks
Title
Change in QoL (EORTC QLQ-H&N35) from baseline
Description
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).
Time Frame
Up to 7 weeks
Title
Number and type of opioid analgesics
Description
The use of opioid analgesics prescribed for oral mucositis pain is assessed.
Time Frame
Up to 7 weeks
Title
Frequency of adverse events
Description
AEs occurred during a clinical trial are assessed by the Investigator in terms of seriousness and relationship with the investigational product.
Time Frame
Up to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Orszagos Onkologiai Intezet, Gyogyszertar
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Centrum Onkologii im. Prof. Franciszka Łukaszczyka Apteka Szpitalna
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o. o.,
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach -
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie
City
Łódź
ZIP/Postal Code
95-513
Country
Poland

12. IPD Sharing Statement

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Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

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