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NCT05994638 Clinical Trial

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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05994638
Other study ID # 08-AP-ONCOS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 21, 2023
Est. completion date November 30, 2023

Study information
Verified date August 2023
Source AronPharma Sp. z o. o.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Poland Uniwersyteckie Centrum Stomatologiczne GUMed Gdansk

Sponsors (1)
Lead Sponsor Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Side effects after radiotherapy Based on a questionnaire Baseline, 1 month
Secondary Impact of dysphagia on quality of life Based on a MDADI questionnaire Baseline, 1 month
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