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

AronPharma

Status

Enrolling

Conditions

Oral Mucositis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05994638

08-AP-ONCOS

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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