Chemotherapy-induced Diarrhea
Conditions
Brief summary
The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).
Interventions
DRUGInactivated Bacteroides fragilis
Live Biotherapeutic Products
DRUGPlacebo
Placebo
Sponsors
Shenzhen Hospital of Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures. 2. Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender. 3. Patients with malignant tumors confirmed by pathology or cytology. 4. Patients scheduled to receive the following initial treatments at the standard dose specified in the protocol: * Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin); * Cohort 2: Patients with breast cancer receiving neratinib treatment. 5. ECOG performance status score of 0-1 at the start of the study. 6. Expected survival time ≥ 12 weeks. 7. Subjects of childbearing potential (including males and females) agree to adopt effective contraceptive measures approved by the investigators (e.g., intrauterine device, contraceptive pills or condoms) during the trial and within 3 months after the trial ends. Female subjects of childbearing potential must have a negative result in serum human chorionic gonadotropin (hCG) test.
Exclusion criteria
1. History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization. 2. Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc. 3. Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial. 4. Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy. 5. Medical history of chronic use of laxatives (≥ 30 non-consecutive days). 6. Need for antibiotic treatment during the trial or long-term use of antibiotics prior to randomization. 7. Patients with stomas, including temporary stomas that have not been closed or patients whose bowel function has not recovered after stoma closure. 8. Presence of unhealed surgical wounds, ulcers or fractures. 9. Known history of human immunodeficiency virus (HIV) infection (positive HIV antibody test). 10. History of allergy or suspected allergy to antidiarrheal drugs (e.g., loperamide and its components). 11. Suspected or confirmed history of alcohol or drug abuse. 12. Pregnant or lactating women. 13. Concurrent participation in other clinical trials. 14. Other conditions deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Incidence of Diarrhea | 4 weeks | Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥2 Diarrhea | 4 weeks | Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0 |
| Incidence of Grade ≥3 Diarrhea | 4 weeks | Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0 |
| Days of Diarrhea | 4 weeks | Mean Days of Diarrhea per Treatment Cycle |
| Frequency of Diarrhea | 4 weeks | Mean Frequency of Stool Type 6 or 7 per Treatment Cycle |
| Percentage and Days of Patients Receiving Antidiarrheal Treatment | 4 weeks | Percentage of patients treated with antidiarrheal drugs (loperamide, diphenoxylate, octreotide, montmorillonite), defined as the proportion of patients with at least one dose of antidiarrheal drugs relative to the total number of cases; days of antidiarrheal treatment, defined as the mean days of antidiarrheal drug administration per treatment cycle. |
| Proportion of Patients Who Received Medical Treatment for Diarrhea | 4 weeks | Proportion of patients who sought medical attention due to diarrhea and received intravenous fluid replacement or anti-infective treatment from investigators. |
| Proportion of Patients Who Had Chemotherapy/Treatment Dose Reduction, Delay or Discontinuation Due to Diarrhea | 4 weeks | Proportion of patients with chemotherapy/treatment dose reduction, delay or discontinuation as judged by investigators due to diarrhea. |
| Relative Dose Intensity of Chemotherapy/Treatment | 4 weeks | Ratio of delivered dose intensity (mg/m² or mg) to planned dose intensity (mg/m² or mg) |
| Incidence of Other Gastrointestinal Symptoms | 4 weeks | Proportion of patients with at least one episode of any grade of gastrointestinal symptoms (constipation, abdominal distension, abdominal pain, hematochezia, nausea, vomiting) assessed by CTCAE v5.0. |
| Change in Quality of Life Score of Cancer Patients Compared with Baseline | 4 weeks | Defined as the change in the QLQ-C30 quality of life scale score of cancer patients after study intervention compared with the baseline. |
| Incidence of Adverse Event (AE) | 4 weeks | Proportion of participants with adverse events as assessed by CTCAE v5.0 |
| Incidence of Serious Adverse Event (SAE) | 4 weeks | Proportion of participants with Serious Adverse Event (SAE) as assessed by GCP 2020 |
Countries
China
Contacts
CONTACTZhou
Outcome results
None listed