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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosol for use in the oral cavity | Experimental | Group of 10 patients with head and neck cancer who have undergone radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3) | Dietary Supplement | Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects after radiotherapy | Based on a questionnaire | Baseline, 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of dysphagia on quality of life | Based on a MDADI questionnaire | Baseline, 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersyteckie Centrum Stomatologiczne GUMed | Recruiting | Gdansk | 80-204 | Poland |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000336 | Aerosols |
| D006820 | Hyaluronic Acid |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| D004935 |
| Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006025 |
| Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |