Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

Study Overview
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Brief Summary
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The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.

Detailed Description
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The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.

Official Title
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Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

Conditions
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Oral Mucositis

Intervention / Treatment
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* Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men, 18-75 years old Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis Patients with dryness in mouth Signed informed consent. Exclusion Criteria: Intake of supplements containing plant extracts, polyphenols or anthocyanins Participation in another clinical trial, Women who are pregnant, planning to become pregnant during the study or breastfeeding, Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation. Hypersensitivity/allergy to any of the ingredient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosol for use in the oral cavity<br>Group of 10 patients with head and neck cancer who have undergone radiotherapy | Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)<br>* Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects after radiotherapy | Based on a questionnaire | Baseline, 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of dysphagia on quality of life | Based on a MDADI questionnaire | Baseline, 1 month | 

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