Radiation-Induced MucositisPhase 4BOOMNCT05055726

Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)

A Phase 4 study testing Benzydamine Hydrochloride 0.15% w/v oromucosal solution in people with Radiation-Induced Mucositis and Head and Neck Cancer, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Radiation-Induced Mucositis, Head and Neck Cancer
What is being tested?: Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 10 sitesin 2 countries
Study dates: 6 Dec 2021to 5 Sep 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Hungary6 sites

Orszagos Onkologiai Intezet, Gyogyszertar
Budapest, 1122
Debreceni Egyetem Klinikai Kozpont, Intezeti Gyogyszertar
Debrecen, 4032
Petz Aladar Egyetemi Oktato Korhaz, Intezeti Gyogyszertar,
Győr, 9024
Somogy Megyei Kaposi Mor Oktato Korhaz - Eszaki Tomb, 1. Emelet, 4. Szarny, Klinikai - Vizsgalati Egyseg.
Kaposvár, 7400
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Klinikai Kutatasi Osztaly
Nyíregyháza, 4400
Csolnoky Ferenc Korhaz, Onkologiai Centrum Sugarterapias Osztaly
Veszprém, 8200

Other trials in Hungary

Poland4 sites

Centrum Onkologii im. Prof. Franciszka Łukaszczyka Apteka Szpitalna
Bydgoszcz, 85-796
Szpitale Pomorskie Sp. z o. o.,
Gdynia, 81-519
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii im. M. Kopernika w Lodzi, - Lódzkie
Lodz, 95-513
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach -
Siedlce, 08-110

Other trials in Poland

About this study

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)

Read the 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.

Conditions: Radiation-Induced Mucositis, Head and Neck Cancer
Being tested: Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Keywords: oral mucositis, radiation therapy, head and neck cancer, mouthwash, oromucosal solution, benzydamine
Medical subject headings: Head and Neck Neoplasms, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05055726
Study group	Role	What they receive
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. Receives: Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 7 weeks

Secondary outcomes (14)

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.
Measured: Up to 7 weeks
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".
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
Percentage change in body weight
The percentage change in body weight from baseline is assessed.
Measured: Up to 7 weeks
Number of days of duration of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is assessed as number of days of duration of therapy.
Measured: Up to 7 weeks
Number of days of discontinuation of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is assessed in terms of days of therapy discontinuation.
Measured: Up to 7 weeks
Dose modifications of Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is evaluated as dose modifications of therapy.
Measured: Up to 7 weeks
Delays in Radiotherapy/Chemotherapy
Radiotherapy/Chemotherapy is evaluated as days of delay in therapy.
Measured: Up to 7 weeks
Number of days of hospitalization.
The healthcare resources consumed in terms of number of days of hospitalization due to oral mucositis are evaluated.
Measured: Up to 7 weeks
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)
Measured: Up to 7 weeks
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).
Measured: Up to 7 weeks
Number and type of opioid analgesics
The use of opioid analgesics prescribed for oral mucositis pain is assessed.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20215 Sep 2022

First posted24 Sep 2021
Study start6 Dec 2021
Primary completion5 Sep 2022
Study completion5 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Radiation-Induced MucositisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: multicenter, international, open label, single-group study
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05055726
Sponsor's protocol ID: 030(Z)WO19247
Other IDs: 2020-003306-32
Acronym: BOOM
Status last verified: Nov 2022
First submitted: 23 Jun 2021
Last updated: 16 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
Enrolling by invitationPhase 1/2
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Mucositis Oral, Head & Neck Cancer
Not yet recruiting
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer

All Radiation-Induced Mucositis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05055726
Acronym / sponsor ID: BOOM / 030(Z)WO19247
Conditions: Radiation-Induced Mucositis, Head and Neck Cancer
Keywords: oral mucositis, radiation therapy, head and neck cancer, mouthwash, oromucosal solution, benzydamine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 6 Dec 2021 (actual)
Primary completion: 5 Sep 2022 (actual)
Study completion: 5 Sep 2022 (actual)
First posted: 24 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Benzydamine mouthwash is considered the gold standard among anti-inflammatory agents in the management of oral mucositis in cancer patients.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: multicenter, international, open label, single-group study

Arm	Type	Receives
Benzydamine Hydrochloride 0.15% w/v oromucosal solution	Experimental	Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solutionBenzydamine 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (12 listed)

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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Benzydamine Hydrochloride 0.15% w/v oromucosal solutionBenzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.	Drug	Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Primary outcome

Number of responders
Time frame: Up to 7 weeks
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.

14 secondary outcomes

Number of compliant patients to Benzydamine treatment.
Time frame: Up to 7 weeks
Change score in the World Health Organization oral mucositis grading scale.
Time frame: Up to 7 weeks
Number of days of duration of severe oral mucositis.
Time frame: Up to 7 weeks
Time of onset of severe oral mucositis.
Time frame: Up to 7 weeks
Percentage change in body weight
Time frame: Up to 7 weeks
Number of days of duration of Radiotherapy/Chemotherapy
Time frame: Up to 7 weeks
Number of days of discontinuation of Radiotherapy/Chemotherapy
Time frame: Up to 7 weeks
Dose modifications of Radiotherapy/Chemotherapy
Time frame: Up to 7 weeks
Delays in Radiotherapy/Chemotherapy
Time frame: Up to 7 weeks
Number of days of hospitalization.
Time frame: Up to 7 weeks
Change in QoL (EORTC QLQ C-30) from baseline
Time frame: Up to 7 weeks
Change in QoL (EORTC QLQ-H&N35) from baseline
Time frame: Up to 7 weeks
Number and type of opioid analgesics
Time frame: Up to 7 weeks
Frequency of adverse events
Time frame: Up to 7 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.

Related trials for Radiation-Induced Mucositis

RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
Enrolling by invitationPhase 1/2
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Mucositis Oral, Head & Neck Cancer
Not yet recruiting
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of responders (time frame: Up to 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05055726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.