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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHenan Cancer Hospital

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Oral cryotherapy
  • Routine oral care

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators