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

Not Applicable

Recruiting

• Conditions: Oral Mucositis
• Interventions: Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)

• Registration Number: NCT05994638
• Lead Sponsor: AronPharma Sp. z o. o.

Brief Summary

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

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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-16
• Study Start: 2023-08-21
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerosol for use in the oral cavity	Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)	Group of 10 patients with head and neck cancer who have undergone radiotherapy

Primary Outcome Measures

Name	Time	Method
Side effects after radiotherapy	Baseline, 1 month	Based on a questionnaire

Secondary Outcome Measures

Name	Time	Method
Impact of dysphagia on quality of life	Baseline, 1 month	Based on a MDADI questionnaire

Trial Locations

Locations (1)

Uniwersyteckie Centrum Stomatologiczne GUMed; 🇵🇱 Gdańsk, Poland