Back to resultsPolyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Primary Purpose
Oral Mucositis
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Radiotherapy, Head and neck cancer, Dysphagia, Oral Mucositis
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
Sites / Locations
- Uniwersyteckie Centrum Stomatologiczne GUMedRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aerosol for use in the oral cavity
Arm Description
Group of 10 patients with head and neck cancer who have undergone radiotherapy
Outcomes
Primary Outcome Measures
Side effects after radiotherapy
Based on a questionnaire
Secondary Outcome Measures
Impact of dysphagia on quality of life
Based on a MDADI questionnaire
Full Information
NCT ID
NCT05994638
First Posted
August 9, 2023
Last Updated
October 12, 2023
Sponsor
AronPharma Sp. z o. o.
1. Study Identification
Unique Protocol Identification Number
NCT05994638
Brief Title
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Official Title
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Radiotherapy, Head and neck cancer, Dysphagia, Oral Mucositis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerosol for use in the oral cavity
Arm Type
Experimental
Arm Description
Group of 10 patients with head and neck cancer who have undergone radiotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
Intervention Description
Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3
Primary Outcome Measure Information:
Title
Side effects after radiotherapy
Description
Based on a questionnaire
Time Frame
Baseline, 1 month
Secondary Outcome Measure Information:
Title
Impact of dysphagia on quality of life
Description
Based on a MDADI questionnaire
Time Frame
Baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Uniwersyteckie Centrum Stomatologiczne GUMed
City
Gdańsk
ZIP/Postal Code
80-204
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Khaidakov, PhD
Phone
798 210 651
Ext
+48
Email
barbara.khaidakov@aronpharma.pl
First Name & Middle Initial & Last Name & Degree
Iwona Ordyniec-Kwaśnica, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
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