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NOT YET RECRUITING
NCT06934733
NA

The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

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

Official title: The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer: A Randomized, Controlled, Multicenter Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-05

Completion Date

2027-05

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

OTHER

Oral cryotherapy

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.

OTHER

Routine oral care

Patients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China