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

Not Applicable

Not yet recruiting

• Conditions: Advanced or Metastatic Breast Cancer

• Registration Number: NCT06934733
• Lead Sponsor: Henan Cancer Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

1. Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.

2. Age ≥ 18 years at the time of informed consent signing.

3. Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.

4. ECOG PS: 0-2 points;

5. The expected survival time was more than 3 months;

6. Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:

   1. Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
   2. Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
   3. Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
   4. Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.

7. Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.

8. Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.

Exclusion Criteria

1. Prior TROP2-targeted treatment was administered.
2. Patients with active oral mucositis or oral ulcers were excluded.
3. 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.
4. Other conditions where the investigator determines the patient is unsuitable for study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)	From the start of TROP2-ADC treatment to the 8th week	The incidence and severity of oral mucositis at week 8

Secondary Outcome Measures

Name	Time	Method
The incidence and severity of oral mucositis at week 12 and week 24	From the start of TROP2-ADC treatment to the 12th and 24th week	The incidence and severity of oral mucositis at week 12and week 24
Progression-free survival(PFS)	Up to approximately 28 weeks	The Time from randomization to tumor progression or death due to any cause
Treatment interruption rate	Up to approximately 28 weeks	Time from the initial administration of TROP2-ADC to treatment interruption

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China