oral mucositis
Conditions
Interventions
Clinical Trial Group:Yuyang mouthwash 10–15 mL twice daily
rinse for 30 s and expectorate (do not swallow). Start before the first dose of sacituzumab govitecan.
Positive control group:Kangfuxin solution 10 mL three times daily
Blank control group:Sacituzumab govitecan therapy alone with no prophylactic oral medication
Sponsors
Beijing Luhe Medical College Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with malignant tumors confirmed by histology or cytology, initially treated with rucaparib monotherapy; 2. Age over 18, both male and female; 3. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), must have at least one measurable lesion. Measurable lesions should not have received local treatments such as radiotherapy (lesions located in previously irradiated areas can also be selected as target lesions if progression is confirmed and they meet RECIST 1.1 criteria); 4. ECOG: 0–2; 5. Expected survival >=12 weeks; 6. Main organ functions normal, meeting the following criteria: (1) Blood routine test: 1) HB >=90 g/L; 2) ANC >=1.5×10^9/L; 3) PLT >=90×10^9/L; (2) Biochemical test: 1) ALB >=30 g/L; 2) ALT and AST =30 mL/min/1.73 m^2; 7. Subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up; 8. Able to maintain oral hygiene during treatment.
Exclusion criteria
Exclusion criteria: 1. Previously treated with topoisomerase I inhibitors in free form or other formulations; 2. Known history within 6 months prior to first dose of unstable angina, myocardial infarction, or congestive heart failure, or clinically significant arrhythmias requiring antiarrhythmic treatment (except stable atrial fibrillation), or left ventricular ejection fraction <50%; 3. Known history within 6 months prior to first dose of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory diseases; 4. Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months prior to first dose; 5. Patients with a history of or currently suffering from oral mucositis; unhealed dental or oral surgery; acute dental or jaw conditions requiring oral surgery; planning to undergo invasive dental surgery during the study; patients with pulpitis or periodontitis during the screening period; 6. Active severe infection requiring systemic antibiotic treatment within 7 days prior to first dose; 7. Known allergy or intolerance to any study treatment or any excipient; 8. Accompanied by impairment of major organs such as heart, liver, or kidney.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of oral mucositis related to lurbinectedin was observed based on CTCAE 5.0.;TCM syndrome score;Quality of Life Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time taken for toxic and adverse reactions to recover to grade 1;Oral Mucositis Self-Assessment Questionnaire;Objective Response Rate ;Disease Control Rate ;median progression-free survival ;Overall Survival ; | — |
Countries
China
Contacts
Public ContactDong Yan
Beijing Luhe Medical College Affiliated to Capital Medical University
Outcome results
None listed