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

NCT ID: NCT06934733

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral cryotherapy

Group Type: EXPERIMENTAL

Oral cryotherapy

Intervention Type: 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.

Routine oral care

Group Type: OTHER

Routine oral care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Min Yan

Role: CONTACT

ym200678@126.com

+86 15713857388

Other Identifiers

HNCH-MBC17

Identifier Type: -

Identifier Source: org_study_id