Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to: evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy. assess tolerability of SAMITAL and the impact on patients reported outcomes.

Official Title
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Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.

Conditions
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Head-and-neck Squamous Cell Carcinoma, Oral Mucositis

Intervention / Treatment
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* Drug: SAMITAL®
* Drug: Placebo sachets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven squamous cell carcinomas of the head-and-neck Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx Stage III or IV disease without evidence of distant metastases Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy Age ≥ 18 years Karnofsky Performance Status ≥70 Life expectancy ≥6 months Able to swallow and retain oral medication Good state of dentition Patients must be available for treatment and follow-up Confirmation of adequate contraception use by the patient and/or partner Signed informed consent Exclusion Criteria: Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities. Chronic administration of steroids or immunosuppressants Pregnancy.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAMITAL® sachets, oral suspension<br>SAMITAL® sachets for oral suspension, 20 mL, four times a day. | Drug: SAMITAL®<br> <br> |
| Placebo Comparator: Placebo sachets<br>Placebo sachets for oral suspension, 20 mL, four times a day. | Drug: Placebo sachets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period. |  | Within 19 weeks after starting Radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0) |  | Within 19 weeks after starting Radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy