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

NCT06934733 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-04-18

No results posted yet for this study

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

Conditions

  • Advanced or Metastatic Breast Cancer

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.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934733 on ClinicalTrials.gov