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

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ClinicalTrials.gov Identifier: NCT05994638

Recruitment Status : Recruiting

First Posted : August 16, 2023

Last Update Posted : October 13, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AronPharma Sp. z o. o.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oral Mucositis	Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Actual Study Start Date :	August 21, 2023
Estimated Primary Completion Date :	November 30, 2023
Estimated Study Completion Date :	November 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Niacinamide Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aerosol for use in the oral cavity 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) Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3

Outcome Measures

Primary Outcome Measures :

Side effects after radiotherapy [ Time Frame: Baseline, 1 month ]
Based on a questionnaire

Secondary Outcome Measures :

Impact of dysphagia on quality of life [ Time Frame: Baseline, 1 month ]
Based on a MDADI questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994638

Locations

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Poland
Uniwersyteckie Centrum Stomatologiczne GUMed	Recruiting
Gdańsk, Poland, 80-204
Contact: Barbara Khaidakov, PhD 798 210 651 ext +48 barbara.khaidakov@aronpharma.pl
Principal Investigator: Iwona Ordyniec-Kwaśnica, MD

Sponsors and Collaborators

AronPharma Sp. z o. o.

More Information

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Responsible Party:	AronPharma Sp. z o. o.
ClinicalTrials.gov Identifier:	NCT05994638
Other Study ID Numbers:	08-AP-ONCOS
First Posted:	August 16, 2023 Key Record Dates
Last Update Posted:	October 13, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by AronPharma Sp. z o. o.:


Radiotherapy Head and neck cancer Dysphagia Oral Mucositis

Additional relevant MeSH terms:

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Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Niacinamide Hyaluronic Acid	Vitamins Micronutrients Physiological Effects of Drugs Adjuvants, Immunologic Immunologic Factors Viscosupplements Protective Agents Vitamin B Complex

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