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

Sponsor

AronPharma Sp. z o. o. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05994638

Collaborator

(none)

Enrollment

Location

Arm

3.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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)	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 21, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

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

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 [Baseline, 1 month]
Based on a questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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