Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414161
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-19
Brief Title:
Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint Oral Rinse a Double-blind Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15 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 stemprogenitor 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 stemprogenitor 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 EGCGs 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
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 stemprogenitor 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 stemprogenitor 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 EGCGs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None