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Trial Title:
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
NCT ID:
NCT05994638
Condition:
Oral Mucositis
Conditions: Official terms:
Mucositis
Stomatitis
Niacinamide
Hyaluronic Acid
Conditions: Keywords:
Radiotherapy
Head and neck cancer
Dysphagia
Oral Mucositis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
Description:
Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3
Arm group label:
Aerosol for use in the oral cavity
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Uniwersyteckie Centrum Stomatologiczne GUMed
Address:
City:
Gdańsk
Zip:
80-204
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Barbara Khaidakov, PhD
Phone:
798 210 651
Phone ext:
+48
Email:
barbara.khaidakov@aronpharma.pl
Investigator:
Last name:
Iwona Ordyniec-Kwaśnica, MD
Email:
Principal Investigator
Start date:
August 21, 2023
Completion date:
November 30, 2023
Lead sponsor:
Agency:
AronPharma Sp. z o. o.
Agency class:
Industry
Source:
AronPharma Sp. z o. o.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994638
