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Clinical Trials/EUCTR2020-003306-32-HU
EUCTR2020-003306-32-HU
Active, not recruiting
Phase 1

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

Angelini Pharma S.p.A.0 sites100 target enrollmentNovember 20, 2020
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ConditionsOral Mucositis (OM) in patients with head and neck cancer (HNC)MedDRA version: 20.0Level: LLTClassification code 10056468Term: Oral mucosal disorderSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Cancer [C04]
DrugsTantum Verde 0.15% w/v mouthwash

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Oral Mucositis (OM) in patients with head and neck cancer (HNC)
Sponsor
Angelini Pharma S.p.A.
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Angelini Pharma S.p.A.

Eligibility 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 \< 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 80

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.

Outcomes

Primary Outcomes

Not specified

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