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

Last updated: October 12, 2023
Sponsor: AronPharma Sp. z o. o.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Canker Sores

Mucositis

Treatment

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

Clinical Study ID

NCT05994638
08-AP-ONCOS
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women and men, 18-75 years old
  • Patients with head and neck cancer or other types of cancer after radiotherapy whosuffer from oral mucositis
  • Patients with dryness in mouth
  • Signed informed consent.

Exclusion

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

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Uniwersyteckie Centrum Stomatologiczne GUMed

    Gdańsk, 80-204
    Poland

    Active - Recruiting

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