Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446180
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-05-09
Brief Title:
Streptococcus Salivarius K12LipGSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
Sponsor:
The General Hospital of Western Theater Command
Organization:
The General Hospital of Western Theater Command
Study Overview
Official Title:
Streptococcus Salivarius K12LipGSH preventsOral Mucositis in Patients Undergoingintensity Modulated Radiotherapy for Malignant Head and Neck TumorsIncluding Nasopharyngeal Carcinoma A Single Single Arm Prospective Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Radiation-induced oral mucositis RIOM is the most common oral complication of cancer patients receiving radiotherapy andor chemotherapy leading to poor quality of life the investigators previous studies that have reported the use of single SSK12 probiotics in RIOM However SSK12 probiotics alone may lack stability free radical scavenging activity and oral local targetingHere the investigators designed a new oral probiotic K12LipGSH that SSK12 is encapsulated in liposomesLip to enhance its stability and free radical scavenging ability and glutathione GSH transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM The investigators have complete evaluated the treatment outcome of SSK12LipGSH on RIOM mice
The investigators designed a single-center single-arm prospective clinical study to evaluate the efficacy and safety of SsK12LipGSH in the treatment of radioactive oral mucositis in patients with head and neck malignancies
The investigators designed a single-center single-arm prospective clinical study to evaluate the efficacy and safety of SsK12LipGSH in the treatment of radioactive oral mucositis in patients with head and neck malignancies
Detailed Description:
Radiotherapy RT is an important method of treatment for malignant tumors of the head and neck and can be used alone or in combination with chemotherapy as a radical or adjuvant therapy Despite improvements in RT equipment and techniques various acute oral complications persist including oral mucositis OM dry mouth taste dysfunction and oral infections OM is one of the most common acute radiation-related toxicities and approximately 50-70 of patients experience severe OM SOM defined by the WHO scale as grade 3 to 4 The painful inflammation and ulceration associated with OM not only profoundly affect patients ability to eat swallow and speak but also decrease their tolerance to anti-cancer treatment thereby impairing their quality of life QoL significantly and causing interruptions in their cancer treatment Although some clinical strategies for radiation-induced OM have been recommended by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology MASCCISOO their efficacy and safety still need further clinical validation Recent evidence suggests the involvement of oral microbiota in radiationinduced OM and modulation of oral microbiota is promising for the management of OM Streptococcus salivarius K12 is a commercially available oral probiotic with strong oral colonization ability bacteriocin-like inhibitory substance BLIS-producing capability and immunomodulatory properties and has been used to treat oral candidiasis pharyngitis tonsillitishalitosis and otitis media More importantly data from our recent animal study demonstrated that topical use of S salivarius K12 ameliorates radiationinduced OM in mice by modulating the oral microbiota mainly by suppressing oral anaerobes
the investigatorsprevious studies that have reported the use of single SSK12 probiotics in RIOM In 2024 the applicant team published a randomized controlled trial as the first author in the top journal in the field of oncology Journal o f Clinical Oncology which found that Streptococcus salivarius K12 SSK12 can effectively alleviate RIOM in radiotherapy patients with malignant head and neck tumors
However SSK12 probiotics alone may lack stability free radical scavenging activity and oral local targetingHere the investigators designed a new oral probiotic K12LipGSH that SSK12 is encapsulated in liposomesLip to enhance its stability and free radical scavenging ability and glutathione GSH transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM the investigators evaluated the treatment outcome of SSK12LipGSH on RIOM mice
In vitro studies showed that SSK12LipGSH treatment was beneficial for the healing of RIOM mice as reflected by reduced ulcer size increased basal layer epithelial cellularity and mucosal thickness and elevated epithelial proliferation and attenuated apoptosis Genomic results showed that the SSK12LipGSH could improve relevant mRNA pathways to promote RIOM healing In addition SSK12LipGSH treatment reconstituted the oral microbiota and decreased the abundance of oral anaerobes of RIOM miceTherefore the SSK12LipGSH holds promise as a potential approach for preventing and treating radiation-induced oral mucositis
the investigatorsprevious studies that have reported the use of single SSK12 probiotics in RIOM In 2024 the applicant team published a randomized controlled trial as the first author in the top journal in the field of oncology Journal o f Clinical Oncology which found that Streptococcus salivarius K12 SSK12 can effectively alleviate RIOM in radiotherapy patients with malignant head and neck tumors
However SSK12 probiotics alone may lack stability free radical scavenging activity and oral local targetingHere the investigators designed a new oral probiotic K12LipGSH that SSK12 is encapsulated in liposomesLip to enhance its stability and free radical scavenging ability and glutathione GSH transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM the investigators evaluated the treatment outcome of SSK12LipGSH on RIOM mice
In vitro studies showed that SSK12LipGSH treatment was beneficial for the healing of RIOM mice as reflected by reduced ulcer size increased basal layer epithelial cellularity and mucosal thickness and elevated epithelial proliferation and attenuated apoptosis Genomic results showed that the SSK12LipGSH could improve relevant mRNA pathways to promote RIOM healing In addition SSK12LipGSH treatment reconstituted the oral microbiota and decreased the abundance of oral anaerobes of RIOM miceTherefore the SSK12LipGSH holds promise as a potential approach for preventing and treating radiation-induced oral mucositis
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