The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer
Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
Age ≥ 18 years at the time of informed consent signing.
Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
ECOG PS: 0-2 points;
Prior TROP2-targeted treatment was administered.
Patients with active oral mucositis or oral ulcers were excluded.
Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
Other conditions where the investigator determines the patient is unsuitable for study participation.
Parallel
Oral cryotherapy
Other interventionPatients randomly assigned to the experimental group underwent TROP2-ADC treatment. They continuously held ice cubes and ice water from 15 minutes before the infusion, throughout the infusion process, and for 15 minutes after the infusion. Ice cubes were promptly replaced with fresh ones as they melted. Patients were instructed not to consume any food or liquids orally for 1 hour following the completion of the ice therapy.
Routine oral care
Other interventionPatients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care.
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)
The incidence and severity of oral mucositis at week 8
The incidence and severity of oral mucositis at week 12 and week 24
The incidence and severity of oral mucositis at week 12and week 24
Progression-free survival(PFS)
The Time from randomization to tumor progression or death due to any cause
Treatment interruption rate
Time from the initial administration of TROP2-ADC to treatment interruption
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