BOOM study (Benzydamine Oromucosal solution in Oral Mucositis)

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) - BOOM study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003306-32-HU

Enrollment

100

Registered

2020-11-20

Start date

2021-01-18

Completion date

Unknown

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis (OM) in patients with head and neck cancer (HNC) MedDRA version: 20.0 Level: LLT Classification code 10056468 Term: Oral mucosal disorder System Organ Class: 100000004856

Interventions

Trade Name: Tantum Verde 0.15% w/v mouthwash Product Name: Tantum Verde 0.15% w/v mouthwash Pharmaceutical Form: Mouthwash INN or Proposed INN: benzydamine hydrochloride CAS Number: 132-69-4 Current S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients of any ethnic origin =18 years of age. 2. Patients diagnosed with stage III or IV HNC (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. 3. Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2. 4. 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. 5. Women of childbearing potential or with no menses for a period =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Patients with reported allergy to benzydamine or another component of the formulation used. 2. Any contraindications listed in the local product’s Summary of Product Characteristics (SmPCs). 3. Patients with prior head and neck RT (in the previous 6 months), or patients who received a palliative treatment. 4. Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions. 5. Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.). 6. Patients who use other oromucosal products (over the counter or prescription) for the same disease. 7. Prescription of other rinses (anaesthetics like “magic mouthwashes” or others), except from sodium bicarbonate rinses. 8. Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol, granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel. 9. Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; any therapeutic use in case of overt clinical infections is allowed. 10. Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition. 11. Patients treated with any topical anti-inflammatory/analgesic products for the mucositis. 12. Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator’s assessment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/treatment of radiation-induced oral mucositis, in HNC patients, from first day of RT through end of RT/ETTV ;Secondary Objective: • The compliance to benzydamine treatment, from first day of RT through end of RT/ETTV • The severity of OM, from first day of RT through end of RT/ETTV • The duration and time to onset of severe OM, from first day of RT through end of RT/ETTV • The nutritional status, from first day of RT through end of RT/ETTV • The oncology treatment compliance, from first day of RT through end of RT/ETTV • The healthcare resources consumed, from first day of RT through end of RT/ETTV • The QoL, from first day of RT through end of RT/ETTV • The use of opioid analgesics for OM pain, from first day of RT through end of RT/ETTV • The safety , from first day of RT through end of RT/ETTV ;Primary end point(s): The number of responders, defined as the number of HNC patients with OM pain intensity <5 (NRS), expressed in percentage, at Visits from 0 to 7 /ETTV, will be considered as primary end-point.;Timepoint(s) of evaluation of this end point: Visits from 0 to 7/ETTV	—

Measure

Time frame

Main Objective: To assess the effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/treatment of radiation-induced oral mucositis, in HNC patients, from first day of RT through end of RT/ETTV ;Secondary Objective: • The compliance to benzydamine treatment, from first day of RT through end of RT/ETTV • The severity of OM, from first day of RT through end of RT/ETTV • The duration and time to onset of severe OM, from first day of RT through end of RT/ETTV • The nutritional status, from first day of RT through end of RT/ETTV • The oncology treatment compliance, from first day of RT through end of RT/ETTV • The healthcare resources consumed, from first day of RT through end of RT/ETTV • The QoL, from first day of RT through end of RT/ETTV • The use of opioid analgesics for OM pain, from first day of RT through end of RT/ETTV • The safety , from first day of RT through end of RT/ETTV ;Primary end point(s): The number of responders, defined as the number of HNC patients with OM pain intensity <5 (NRS), expressed in percentage, at Visits from 0 to 7 /ETTV, will be considered as primary end-point.;Timepoint(s) of evaluation of this end point: Visits from 0 to 7/ETTV

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Secondary

Measure	Time frame
Secondary end point(s): • The number of compliant patients, expressed in percentage, at Visits from 0 to 7/ETTV • The change in score in the WHO oral mucositis grading scale with respect to the baseline, expressed in percentage, at Visits from 0 to 7/ETTV • The number of days of duration and time to onset of severe mucositis (grade 3 or 4 on the WHO), at Visits from 0 to 7/ETTV • The percentage change in body weight between Visit 0 and Visit 7/ETTV; the need for nutritional support (i.e., need of a feeding tube): type of enteral support, i.e., partial or total and number of days of need, at Visits from 0 to 7/ETTV • The number of days of duration of RT/CT administered, number of days of discontinuation, dose modifications, possible delays, at Visits from 0 to 7/ETTV • The number of days of hospitalization whose main reason is mucositis or one of its complications, at Visits from 0 to 7/ETTV • The change in QoL with respect to Visit 0, at all the visits up to Visit 7/ETTV • The number and type of opioid analgesics used for OM pain, at Visits from 0 to 7/ETTV • The changes from baseline in vital signs, physical examination and adverse events, at Visits from 0 to 7/ETTV ;Timepoint(s) of evaluation of this end point: Visits from 0 to 7/ETTV	—

Measure

Time frame

Secondary end point(s): • The number of compliant patients, expressed in percentage, at Visits from 0 to 7/ETTV • The change in score in the WHO oral mucositis grading scale with respect to the baseline, expressed in percentage, at Visits from 0 to 7/ETTV • The number of days of duration and time to onset of severe mucositis (grade 3 or 4 on the WHO), at Visits from 0 to 7/ETTV • The percentage change in body weight between Visit 0 and Visit 7/ETTV; the need for nutritional support (i.e., need of a feeding tube): type of enteral support, i.e., partial or total and number of days of need, at Visits from 0 to 7/ETTV • The number of days of duration of RT/CT administered, number of days of discontinuation, dose modifications, possible delays, at Visits from 0 to 7/ETTV • The number of days of hospitalization whose main reason is mucositis or one of its complications, at Visits from 0 to 7/ETTV • The change in QoL with respect to Visit 0, at all the visits up to Visit 7/ETTV • The number and type of opioid analgesics used for OM pain, at Visits from 0 to 7/ETTV • The changes from baseline in vital signs, physical examination and adverse events, at Visits from 0 to 7/ETTV ;Timepoint(s) of evaluation of this end point: Visits from 0 to 7/ETTV

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Countries

Hungary

Contacts

Public ContactValerie Tellone

Angelini Pharma S.p.A.

valeria.tellone@angelinipharma.com+393452493461

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026