The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- CTCAE grade 3-4 diarrhea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Eligible participants who meet the inclusion criteria after screening will receive either the investigational product or placebo, packaged and labeled with a unique randomization number, as assigned by an independent investigator. The participants, as well as the researchers involved in recruitment, screening, and follow-up, and the nursing staff, will all be blinded to the group assignments. Unblinding and data analysis will be conducted only after all participants have completed adjuvant chemotherapy.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
intervention group
Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
干预措施: Clostridium butyricum capsules (Drug)
control group
Oral administration of placebo capsules, 6 capsules three times daily, containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.
干预措施: placebo capsules (Other)
结局指标
主要结局
CTCAE grade 3-4 diarrhea
时间窗: Throughout the entire course of adjuvant chemotherapy , up to 6 months
Incidence of grade 3-4 diarrhea during adjuvant chemotherapy, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
次要结局
- Overall incidence of adverse events(Throughout the entire course of adjuvant chemotherapy , up to 6 months)
- rate of adjuvant treatment interruption(Throughout the entire course of adjuvant chemotherapy , up to 6 months)
- White blood cell count(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(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(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(Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.)
- procalcitonin(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(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(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(Throughout the entire course of adjuvant chemotherapy , up to 6 months)
研究者
Zhou Yanbing
The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University