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Набор скоро начнётся NCT07152886

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer

Фаза IV С лечением Colorectal Cancer Chemotherapeutic Toxicity

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: Clostridium butyricum capsules, placebo capsules.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Chemotherapeutic Toxicity. Базовые параметры: 18 лет — 70 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Обзор

This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.

Подробное описание

A total of 238 participants who have undergone radical resection for colorectal cancer and are scheduled to initiate adjuvant chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to the intervention group or the control group. During adjuvant chemotherapy, participants in the intervention group will receive Clostridium butyricum capsules, while those in the control group will receive a placebo. The primary outcome is the incidence of CTCAE grade 3-4 diarrhea during adjuvant chemotherapy.

Вмешательства

  • Препарат Clostridium butyricum capsules
    Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
  • Другое placebo capsules
    Oral administration of placebo capsules, 6 capsules tid., containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.

Первичные конечные точки

  • CTCAE grade 3-4 diarrhea [Срок оценки: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
Вторичные конечные точки (10)
  • Overall incidence of adverse events [Срок оценки: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
  • rate of adjuvant treatment interruption [Срок оценки: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
  • White blood cell count [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • neutrophil count [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • lymphocyte count [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • C-reactive protein [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • procalcitonin [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • serum albumin [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • serum procalcitonin [Срок оценки: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • completion rate of the planned adjuvant therapy [Срок оценки: Throughout the entire course of adjuvant chemotherapy , up to 6 months]

Критерии участия

Критерии включения

  • Aged 18-70 years;
  • No restriction on gender;
  • Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);
  • ECOG performance status score of 0-2;
  • Signed informed consent

Критерии исключения

  • Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment;
  • Presence of psychiatric disorders or other conditions that prevent cooperation with the intervention;
  • Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;
  • Participation in other clinical studies within 3 months prior to enrollment;
  • History of inflammatory bowel disease;
  • History of autoimmune diseases;
  • Pregnancy or breastfeeding;
  • Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery;
  • Underwent ostomy surgery during the operation (including temporary or permanent ostomy).

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • The Affiliated Hospital of Qingdao University — Qingdao

Идентификаторы

NCT: NCT07152886 · DHQDFY-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗