Using green tea and peppermint to manage dry mouth from radiotherapy
Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint Oral Rinse: a Double-blind, Randomized Clinical Trial
This study is testing if a mouth rinse made from green tea and peppermint can help people with dry mouth caused by radiotherapy for head and neck cancer feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06414161 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mouth rinse made from green tea and peppermint in alleviating xerostomia, a common side effect of radiotherapy in head and neck cancer patients. The primary objective is to measure subjective dry mouth scores, while secondary objectives include assessing salivary flow rates and objective dry mouth scores. The study aims to provide a non-pharmacological intervention to improve the quality of life for patients suffering from this condition. Participants will be monitored for their responses to the treatment over a specified period.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old who are experiencing xerostomia with specific dry mouth scores.
Not a fit: Patients with serious illnesses, autoimmune diseases, or those who are pregnant or part of vulnerable groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients experiencing dry mouth due to radiotherapy.
How similar studies have performed: While there are existing treatments for xerostomia, the use of green tea and peppermint as a mouth rinse is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both genders, aged above 20 years. * All patients must have complaint of xerostomia. * Objective dry mouth score from ( 2-5). * Subjective dry mouth score from (1-4). * Patients must be able to make reliable decision or communications. Exclusion Criteria: * - Smoking, Alcohol. * Patient with history of any serious illness as malignancy. * Patients with any autoimmune disease. * Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Where this trial is running
Cairo and 1 other locations
- Ahmed Maher Teaching Hosipital — Cairo, Egypt (Recruiting)
- ain shams University — Cairo, Egypt (Completed)
Study contacts
- Study coordinator: Fatma E.Sayed A Hassanein
- Email: fatmahassanein@dent.asu.edu.eg
- Phone: +201000093885
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.