Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285591
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-06
Brief Title:
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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 therapy is a common treatment modality in the management of head and neck malignancies However head and neck tumors often have some adverse reactions when receiving radiation therapy such as dry mouth change of taste oral mucositis etc Among them the incidence of oral mucositis is more than 90 and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50 Severe oral mucositis seriously affects the quality of survival of patients Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract skin etc Among them Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry and are common Lactobacillus strains marketed for the production of oral probiotics which are commonly used in infant formulas among others In oral inflammatory diseases it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria In terms of safety oral Lactobacillus Reuteri has good stability very low pathogenic potential and is not toxic to humans Therefore this study is a placebo-controlled multi-center open randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors including nasopharyngeal carcinoma
Detailed Description:
Radiotherapy RT is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy Despite improvements in RT equipment and techniques there are still a variety of acute oral complications including oral mucositis OM xerostomia taste dysfunction and oral infection OM is one of the most common acute radiation-related toxicity in head and neck malignant tumor patients receiving RT and approximately 5070 of patients experience severe oral mucositis SOM The painful inflammation and ulceration associated with OM not only profoundly affect patients ability to eat swallow and speak but also decrease patients tolerance to anti-cancer treatment seriously impairing patients quality of life QoL and causing interruptions and cancellations of cancer treatment Standard treatment for OM focuses on pain control rehydration and good oral hygiene For patients with hematopoietic stem cell transplantation palifermin keratinocyte growth factor-1 is recommended Although some clinical strategies for OM such as non-steroidal anti-inflammatory drugs mucosal protective agents growth factors and cytokines antibacterial and pain relief drugs have been recommended by the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology MASCCISOO the therapeutic benefit is limited6 Thus it is crucial to develop effective drugs or treatment strategies to decrease radiation-induced mucosal toxicity
The resident microbiota plays an important role in the pathogenesis and development of radiation-induced OM Microbiota can release pathogen-associated molecular patterns PAMPs that bind to pathogen recognition receptors PRR and activate the initial innate immune response a known pathogenic pathway Recent studies have suggested that dysbiosis of oral microbial contributes to the occurrence and severity of radiation-induced OM and manipulation of the patient microbial community may be key to preventing and treating effectively OM Probiotics are defined as live microorganisms which when administered in adequate amounts can improve the microecological balance and confer a health benefit on the host Conventional probiotics typically belong to the genera Lactobacillus or Bifidobacterium and Lactobacillus brevis CD2 is the most widely studied probiotic for preventing cancer therapy-induced OM but its effectiveness is still debated
Lactobacillus Reuteri is the bodys natural flora and can be found in the gastrointestinal tract skin breast milk etc And they do not trigger infections in healthy individuals15 Among them Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry and are common Lactobacillus strains used in the market for making oral probiotics16 Lactobacillus Reuteri DSM 17938 has been reported to alleviate chronic inflammatory conditions such as infantile colic and irritable bowel-syndrome17In oral inflammatory diseases Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 have been found to reduce gingival and periodontal inflammation which is mainly achieved through mechanisms such as modulation of the host inflammatory response and displacement of pathogenic bacteria The development of oral mucositis caused by radiotherapy or chemoradiotherapy is associated with DNA damage and high production of various inflammatory factors such as interleukin-1IL-1 interleukin-6 IL-6 and tumor necrosis factor-aTNF-a Recently the results of the study by Nitasha et al showed that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce oxidative stress and Inflammation in a preclinical rodent model All of the above imply Lactobacillus reuteris potential use in the prevention of OM
The purpose of this placebo-controlled randomized trial was to investigate the prevention effects of Lactobacillus Reuteri versus placebo in patients with head and neck malignant tumors receiving RT
The resident microbiota plays an important role in the pathogenesis and development of radiation-induced OM Microbiota can release pathogen-associated molecular patterns PAMPs that bind to pathogen recognition receptors PRR and activate the initial innate immune response a known pathogenic pathway Recent studies have suggested that dysbiosis of oral microbial contributes to the occurrence and severity of radiation-induced OM and manipulation of the patient microbial community may be key to preventing and treating effectively OM Probiotics are defined as live microorganisms which when administered in adequate amounts can improve the microecological balance and confer a health benefit on the host Conventional probiotics typically belong to the genera Lactobacillus or Bifidobacterium and Lactobacillus brevis CD2 is the most widely studied probiotic for preventing cancer therapy-induced OM but its effectiveness is still debated
Lactobacillus Reuteri is the bodys natural flora and can be found in the gastrointestinal tract skin breast milk etc And they do not trigger infections in healthy individuals15 Among them Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry and are common Lactobacillus strains used in the market for making oral probiotics16 Lactobacillus Reuteri DSM 17938 has been reported to alleviate chronic inflammatory conditions such as infantile colic and irritable bowel-syndrome17In oral inflammatory diseases Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 have been found to reduce gingival and periodontal inflammation which is mainly achieved through mechanisms such as modulation of the host inflammatory response and displacement of pathogenic bacteria The development of oral mucositis caused by radiotherapy or chemoradiotherapy is associated with DNA damage and high production of various inflammatory factors such as interleukin-1IL-1 interleukin-6 IL-6 and tumor necrosis factor-aTNF-a Recently the results of the study by Nitasha et al showed that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce oxidative stress and Inflammation in a preclinical rodent model All of the above imply Lactobacillus reuteris potential use in the prevention of OM
The purpose of this placebo-controlled randomized trial was to investigate the prevention effects of Lactobacillus Reuteri versus placebo in patients with head and neck malignant tumors receiving RT
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