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Набор скоро начнётся NCT06934733

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

Без фазы С лечением Advanced or Metastatic Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oral cryotherapy, Routine oral care.
Кому может быть актуально
Состояния в реестре: Advanced or Metastatic Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

  • The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard) [Срок оценки: From the start of TROP2-ADC treatment to the 8th week]
Вторичные конечные точки (3)
  • The incidence and severity of oral mucositis at week 12 and week 24 [Срок оценки: From the start of TROP2-ADC treatment to the 12th and 24th week]
  • Progression-free survival(PFS) [Срок оценки: Up to approximately 28 weeks]
  • Treatment interruption rate [Срок оценки: Up to approximately 28 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Henan Cancer Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT06934733 · HNCH-MBC17

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗