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

AronPharma Sp. z o. o.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Oral Mucositis

Interventions

Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)DIETARY_SUPPLEMENT

Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Uniwersyteckie Centrum Stomatologiczne GUMed

Gdansk, Poland

RECRUITING

Outcomes

Primary Outcomes

Side effects after radiotherapy

Based on a questionnaire

Time frame: Baseline, 1 month

Secondary Outcomes

Impact of dysphagia on quality of life

Based on a MDADI questionnaire

Time frame: Baseline, 1 month

Data from ClinicalTrials.gov

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