Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint

NCT06414161 | Recruiting

• 1 other identifier: green tea and peppermint
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to evaluate the clinical effectiveness of a mix of (green tea and peppermint) mouth rinse using the subjective dry mouth score as a primary objective and to assess the effect of that mix on the salivary flow rate and objective dry mouth score as a secondary objective.

Conditions

Radiation-induced Xerostomia

Keywords

xerostomia; green tea; pepprmint; Mucositis

Outcome Measures

Primary Outcomes (1)

• Subjective symptoms of oral dryness

  Using a questionnaire will be recorded according to the following: Q1. Does your mouth feel dry? Q2. Do you sip liquids to aid in swallowing dry food? Q3. Does your mouth feel dry when eating a meal? Q4. Does the amount of saliva in your mouth seem to be too little? Subject who answered affirmatively to at least one of the questions related to oral dryness will be considered as positive for subjective complaints of oral dryness. the score range frpm 1-4 according to the number of questions answered by yes

  Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Secondary Outcomes (1)

• Objective dry mouth score

  Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Study Arms (2)

Intervention group:

EXPERIMENTAL

patients in test group will topically apply 20 ml (green tea plus peppermint) (1:1) to the oral mucosa. They will be instructed to keep green tea plus peppermint for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of green tea plus peppermint in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy.

Dietary Supplement: mix of (green tea and peppermint)

Control group

PLACEBO COMPARATOR

Patients in the control arm will topically apply 20 mL of 0.9% of saline 15 min before and after radiotherapy. They will be advised to rinse saline. They will be instructed to keep saline for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of saline in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy.

Dietary Supplement: mix of (green tea and peppermint)

Interventions

mix of (green tea and peppermint) DIETARY_SUPPLEMENT

Dried green tea leaves (100 gm) will be soaked into 500 ml of methanol solution for two days. The solution obtained will then be strained by a strainer and shifted to a glass plate. The plates will be left at room temperature from three to four days. Scraping out of the crystal powder of the extract from the plates will be carried out \[27\]. The peppermint mouth rinse that was used in this study had 1% peppermint base, 10% xylisorb, 5% glycerin, 1% Tween 20%, 5% alcohol 96%, 0/18% methyl paraben, and 0/02% propyl paraben \[28\]. Similarly, green tea plus peppermint mouthwash will be prepared at the same way but by adding 50% green tea leaves and 50% peppermint in the extract.

Control group; Intervention group:

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ahmed Maher Teaching Hosipital

Cairo, 11565, Egypt

RECRUITING

ain shams University

Cairo, 11565, Egypt

COMPLETED

MeSH Terms

Conditions

Xerostomia; Mucositis

Interventions

Tea

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• dalia Ghalwash

  professor

  STUDY DIRECTOR

Central Study Contacts

Fatma E.Sayed A Hassanein

CONTACT

+201000093885; fatmahassanein@dent.asu.edu.eg

Asma A. Abou Bakr

CONTACT

Asmaa.Aboubakr@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 16, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)