Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint

NCT ID: NCT06414161

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

The Global Cancer Observatory from the World Health Organization estimates that head and neck cancer (HNC) incidence will reach approximately 1.5 million cases worldwide in 2020. Nevertheless, radiotherapy (RT) remains one of the cornerstone standard therapies to attenuate HNC progression. The advancement of linear accelerator (LINAC) technologies together with intensity-modulated radiation therapy (IMRT) techniques have enhanced the precision and efficiency of fractionated RT for HNC. Emerging research efforts have also been undertaken to understand these RT technologies' ability to spare the function of neighboring healthy tissues or organs like the salivary glands (SG).

Despite these research advances, a large majority of HNC patients who undergo RT display irreversible dry mouth symptoms (xerostomia) due to high radiation sensitivity of salivary gland (SG) secretory cells. This gland damage is thought to be triggered by an RT-induced loss of acinar cells and a potential impairment of the parasympathetic innervation and vascularization. Hence, the remaining integral SG stem/progenitor cells post-RT will define the true regenerative ability of the SG organ.

Cytoprotectant agents like amifostine have been recommended to prevent RT damage to SG cells. Amifostine is the only US Food and Drug Administration (FDA) approved drug for this prevention strategy. In Phase III clinical trials, amifostine was found to reduce xerostomia severity in subjects with grade two and above; however, more than 50% of subjects still presented acute xerostomia symptoms and oral mucosa inflammation. Moreover, amifostine has a very narrow therapeutic window. Therefore, frequent administration is required leading to severe side effects in more than half of the treated individuals. These side effects can lead to the discontinuation of amifostine treatment and RT delay in 25% of HNC patients. The high frequency of reported side effects and its high cost and low-quality evidence of efficacy from several clinical trials make amifostine a less promising pharmacological approach. Thus, novel pharmaceuticals are necessary to prevent SG damage and maintain the acinar epithelial and stem/progenitor cell populations in the SG organ.

In vitro and in vivo studies indicate green tea polyphenols (GTPs)/(-)-epigallocatechin-3-gallate (EGCG) as potential natural agents for xerostomia management, potentially delaying salivary dysfunction through molecular mechanisms. Researchers highlighted EGCG's role in suppressing autoantigens, influencing epithelial cell proliferation, and modulating antioxidant enzyme expression in salivary glands.

Peppermint essential oil is another herbal preparation with strong antibacterial and cooling effects. As a safe herbal preparation, peppermint essential oil has been found to be effective in alleviating the pain associated with aphthous stomatitis and managing dental plaque.

Conditions

Radiation-induced Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group:

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.

Group Type: EXPERIMENTAL

mix of (green tea and peppermint)

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

mix of (green tea and peppermint)

Intervention Type: 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.

Interventions

mix of (green tea and peppermint)

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

dalia Ghalwash

Role: STUDY_DIRECTOR

professor

Locations

Ahmed Maher Teaching Hosipital

Cairo, , Egypt

Site Status: RECRUITING

ain shams University

Cairo, , Egypt

Site Status: COMPLETED

Countries

Egypt

Central Contacts

Fatma E.Sayed A Hassanein

Role: CONTACT

fatmahassanein@dent.asu.edu.eg

+201000093885

Asma A. Abou Bakr

Role: CONTACT

Asmaa.Aboubakr@bue.edu.eg

Facility Contacts

Fatma E.Sayed A Hassanein

Role: primary

fatmahassanein@dent.asu.edu.eg

+201000093885

Other Identifiers

green tea and peppermint

Identifier Type: -

Identifier Source: org_study_id