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The randomized placebo-controlled trial of Activated charcoal for prevention of chemotherapy induced diarrhea from grade 3 and above from irinotecan in FOLFIRI regimen in advanced colorectal cancer

The randomized placebo-controlled trial of Activated charcoal for prevention of chemotherapy induced diarrhea from grade 3 and above from irinotecan in 5-Fluorouracil-Folinic acid-Irinotecan regimen in advanced colorectal cancer

Status
Unknown
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240615003
Enrollment
30
Registered
2024-06-15
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced stage colorectal cancer that recieves FOLFIRI chemotherapy regimen activated charcoal , quality of life , colorectal cancer,chemotherapy induced diarrhea ,irinotecan ,

Interventions

patients with advanced colorectal cancer who are receiving the FOLFIRI chemotherapy regimen. These patients will be randomly assigned to receive activated charcoal as a prophylactic treatment.,patient
Experimental Drug,Placebo Comparator Drug
activated charcoal arm ,placebo arm

Sponsors

Rajavithi hospital, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 advanced colorectal cancer 2 receive FOLFIRI chemotherapy with irinotecan 160 mg/m2 every 2 week 3 age >= 18 years 4 ECOG score 0-1

Exclusion criteria

Exclusion criteria: 1 patients with baseline diarrhea > 4 times /day 2 patients with ileostomy 3 patient receive anti EGFR therapy 4 patient with pregnancy or breastfeeding 5allergic to activated charcoal 6 patients who are at risk for bowel obstruction 7 patients with baseline constipation 8 patients with baseline vomiting 9 patients with baseline abdominal pain

Design outcomes

Primary

MeasureTime frame
diarrhea above grade 2 definition increase of stool more than 7 times per day over baseline or hospitalization indicated 2 weeks manual diarhea count :

Secondary

MeasureTime frame
diarrhea all grades definition collective occurrence of diarrhea at different severity level 2 weeks manual diarrhea count

Countries

Thailand

Contacts

Public ContactNattagorn Taweepoca

rajavithi hospital

timetales@hotmail.com0824913806

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026