Using a polyphenol-rich aerosol to help cancer patients reduce side effects from radiation therapy
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
This study is testing a new plant-based spray to see if it can help cancer patients undergoing radiation therapy feel better by reducing side effects like mouth discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AronPharma Sp. z o. o. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Gdańsk) |
| Trial ID | NCT05994638 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a polyphenol-rich aerosol in alleviating side effects experienced by cancer patients, particularly those undergoing radiation therapy for head and neck cancer. A total of 10 patients will be treated with the aerosol for one month, and their side effects will be assessed using questionnaires before and after the treatment. The aerosol contains a mixture of plant extracts, hyaluronic acid, and vitamin B3, which are believed to support oral health and minimize discomfort associated with oral mucositis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with head and neck cancer who are experiencing oral mucositis after radiation therapy.
Not a fit: Patients who are currently taking supplements with similar ingredients or those with certain autoimmune diseases or severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for cancer patients by reducing the discomfort associated with radiation therapy.
How similar studies have performed: While the specific approach of using a polyphenol-rich aerosol is novel, similar studies have shown promise in using plant extracts to alleviate side effects of cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gdańsk
- Uniwersyteckie Centrum Stomatologiczne GUMed — Gdańsk, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.