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Chlorophyllin for Late Radiation-induced Luminal Gastrointestinal Tract Bleeding
NCT07837713Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Sep 2028
- Countries
- 1
- Sponsor
- Tata Memorial Centre
- Conditions
- Gastrointestinal Bleeding (GIB)
01
Overview
Phase 3, randomised, double-blind trial in Gastrointestinal Bleeding (GIB) comparing Sodium Copper Chlorophyllin (CHL) with Placebo (2 arms). Primary endpoint: Grade 2 or higher anemia due to uncontrolled bleeding at 6 months. Planned start Sep 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sodium Copper Chlorophyllin (CHL)
Oral sodium copper chlorophyllin 500 mg once daily for 3 months + standard medical management.
Placebo
Matching placebo once daily for 3 months + standard medical management.
03
Who it enrols
Adults with histologically confirmed malignancy who developed late radiation-induced luminal GI bleeding at least 6 months after radiotherapy, with ECOG 0-2 and HB >10 g/dl. Excludes patients with IBD or bleeding tendencies.
04
Endpoints
Primary
Grade 2 or higher anemia due to uncontrolled bleeding
Secondary
Chronic bleeding score
Occult Blood Test Conversion Rate
Symptom Relief in Associated GI Symptom Complex
Endoscopic Response
Anemia profile
Cost of Therapy
Transfusion Rates
Quality of Life QLQ-C30
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