Oral mucositis induced by radiotherapy and chemotherapy
Conditions
Interventions
BG36 group:In the course of concurrent chemoradiotherapy, on the basis of routine oral care, nutritional support and symptomatic treatment, BG36 will be given orally, 40mg/kg/d, and warm water on an e
placebo group:In the course of concurrent chemoradiotherapy, placebo was given on the basis of routine oral care, nutritional support and symptomatic treatment. The appearance and administration of pl
Sponsors
Department of Nutrition, the First Medical Center of Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven head and neck tumors receiving simultaneous chemoradiotherapy for the first time (including postoperative patients); 2. Normal oral mucosa (RTOG oral mucositis Assessment Scale standard level 0); 3. Age 18 to 80 years old (including boundary values), male or female; 4. Volunteer to participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with clear evidence of tumor recurrence or distant metastasis; 2. During the study, patients receiving other medications that may interfere with the evaluator's assessment of mucositis changes; 3. Surgical incisions involving oral mucosa and incomplete postoperative wound healing; 4. Patients with severe hepatic and renal dysfunction, co-existing serious organ diseases, poorly controlled endocrine, metabolic, and immune system disorders, with a significant history or clinical evidence of acute or chronic diseases that may affect the evaluation of mucositis prevention efficacy; 5. Abnormal laboratory test results: - Blood routine: hemoglobin 2.5 times the upper limit of normal; ALP >2.5 times the upper limit of normal; total bilirubin (TBIL) >2 times the upper limit of normal; serum creatinine (SCr) above normal limits; serum albumin (ALB) <30g/L 6. Participation in other interventional clinical trials within 4 weeks prior to screening including drugs, nutritional supplements, and medical devices; 7. Continuous use of immune-enhancing food or drugs within 4 weeks prior to screening; 8.Pregnant or lactating women or baseline pregnancy test-detected women capable of reproduction. 9.Persons with congenital metabolic disorders related to ingredients in this product or known allergies to trial food components. 10.Participants who are unable to comply with study procedures after evaluation,or participants who are unlikely to complete the study due to language barriers or mental health issues .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral mucositis above grade 3 in patients with head and neck tumors during chemoradiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall incidence, severity and duration of oral mucositis in patients with head and neck tumors during chemoradiotherapy;Effect of BG36 on quality of life in patients with oral mucositis induced by radiotherapy and chemotherapy;Effect of BG36 on oral flora of oral mucositis induced by radiotherapy and chemotherapy in patients with head and neck tumors;Effect of BG36 on cellular immunity and humoral immunity in patients with head and neck tumor during chemoradiotherapy;Safety of BG36 in patients receiving chemoradiotherapy for head and neck tumors; | — |
Countries
China
Contacts
Public ContactXuqing
Department of Nutrition, the First Medical Center of Chinese People's Liberation Army General Hospital
Outcome results
None listed