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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
124
Patients 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.
Patients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care.
Henan Cancer Hospital
Zhengzhou, Henan, China
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
Time frame: From the start of TROP2-ADC treatment to the 8th week
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
Time frame: From the start of TROP2-ADC treatment to the 12th and 24th week
Progression-free survival(PFS)
The Time from randomization to tumor progression or death due to any cause
Time frame: Up to approximately 28 weeks
Treatment interruption rate
Time from the initial administration of TROP2-ADC to treatment interruption
Time frame: Up to approximately 28 weeks
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