Chemotherapeutic Toxicity, Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, adjuvant chemotherapy, Clostridium butyricum
Brief summary
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.
Detailed description
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.
Interventions
DRUGClostridium butyricum capsules
Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
OTHERplacebo 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.
Sponsors
Shandong Provincial Hospital
Linyi People's Hospital
Shandong Cancer Hospital and Institute
Yantai Yuhuangding Hospital
Jining First People's Hospital
Rizhao People's Hospital
Qianfoshan Hospital
Weifang People's Hospital
Qilu Hospital of Shandong University
Taian City Central Hospital
The Affiliated Hospital of Shandong Second Medical University
Dongying People's Hospital
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTCAE grade 3-4 diarrhea | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of adjuvant treatment interruption | Throughout the entire course of adjuvant chemotherapy , up to 6 months | defined as a delay of \>=3 weeks from the planned treatment schedule |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| Overall incidence of adverse events | Throughout the entire course of adjuvant chemotherapy , up to 6 months | Overall incidence of adverse events during adjuvant chemotherapy. Severity and specific types will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| procalcitonin | Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
| completion rate of the planned adjuvant therapy | Throughout the entire course of adjuvant chemotherapy , up to 6 months | The total number of adjuvant chemotherapy cycles will be determined by the MDT (Multidisciplinary Team) prior to the initiation of treatment. Completion of the planned number of cycles as specified will be defined as completed. |
| 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. | Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results. |
Countries
China
Contacts
Primary ContactGan Liu
Outcome results
None listed