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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Other: Oral cryotherapy; Other: Routine oral care

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: +86 15713857388; Email: ym200678@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral cryotherapy	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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the start of TROP2-ADC treatment to the 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to approximately 28 weeks
Treatment interruption rate	Time from the initial administration of TROP2-ADC to treatment interruption	Up to approximately 28 weeks

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Skin Diseases; Gastroenteritis; Breast Diseases; Breast Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: HNCH-MBC17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No