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

NCT05994638 | Unknown

• 1 other identifier: 08-AP-ONCOS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Radiotherapy; Head and neck cancer; Dysphagia; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Side effects after radiotherapy

  Based on a questionnaire

  Baseline, 1 month

Secondary Outcomes (1)

• Impact of dysphagia on quality of life

  Baseline, 1 month

Study Arms (1)

Aerosol for use in the oral cavity

EXPERIMENTAL

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)

Interventions

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

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

Aerosol for use in the oral cavity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AronPharma Sp. z o. o.: lead

Study Sites (1)

Uniwersyteckie Centrum Stomatologiczne GUMed

Gdansk, 80-204, Poland

RECRUITING

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms; Deglutition Disorders

Interventions

Aerosols; Hyaluronic Acid; Niacinamide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Glycosaminoglycans; Polysaccharides; Carbohydrates; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 21, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)