EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

Detailed Description
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This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).

Official Title
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A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy

Conditions
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Oral Mucositis, Head and Neck Cancer

Intervention / Treatment
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* Drug: EN3285
* Drug: Placebo
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Significant Inclusion Criteria: 18 years and older newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT. Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx Chemotherapy: cisplatin Have a WBC ≥3500 per cubic millimeter Have a platelet count ≥100,000 per cubic millimeter Have adequate renal function as determined by the principal investigator prior to enrollment Are willing and able to undergo oral assessments Have a Karnofsky Performance Status score ≥70 Significant Exclusion Criteria: Have OM or other oral conditions at study entry Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol Are using a pre-existing feeding tube for nutritional support at study entry Plan to use any drug for the treatment or prevention of OM Have had any prior radiotherapy to the head and neck Have had prior chemotherapy within 6 months preceding enrollment Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug Have medical conditions that require the use of chronic steroid therapy Have the inability to undergo repeat treatments,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN3285 (NAC ProGelz)<br>The EN3285 arm is the product under development | Drug: EN3285<br>* Oral rinse<br>|
| Placebo Comparator: No active ingredients (placebo)<br>This will be an oral product that contains no active ingredient | Drug: Placebo<br>* Oral rinse<br>|
| Other: Standard of Care<br>This arm will reflect the typical standard of care for the patient | Other: Standard of care<br>* This will be the therapy most commonly used the the institution treating the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCI v3 to measure severity of OM |  | At 50 Gy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO criteria for measuring severity of OM |  | At 50 Gy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Mucositis, Chemoradiation therapy, Head and neck cancer