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

NCT06934733 | Not Yet Recruiting

• 1 other identifier: HNCH-MBC17
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Progression-free survival(PFS)

  Up to approximately 28 weeks

• Treatment interruption rate

  Up to approximately 28 weeks

Study Arms (2)

Oral cryotherapy

EXPERIMENTAL

Other: Oral cryotherapy

Routine oral care

OTHER

Other: Routine oral care

Interventions

Oral cryotherapy OTHER

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.

Oral cryotherapy

Routine oral care OTHER

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

Routine oral care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The expected survival time was more than 3 months;
• 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:
• Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
• Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
• Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
• Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
• 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.
• Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Min Yan

CONTACT

+86 15713857388; ym200678@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)