Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Centre
• Collaborator: Bhabha Atomic Research Centre (BARC), Mumbai
• Treatments: Chlorophyllin; Copper

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back.

• Any grade of radiation-induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3).

• Adequate liver function defined as ALT/ALT ≤ 3 times ULN and total bilirubin ≤ 2 times ULN. Elevated transaminases up to 5 times ULN is allowed in patients with liver metastasis.

• Adequate renal function defined as creatine clearance ≥ 30 mL/min (By Cockcroft-Gault formula).

Exclusion Criteria:

• Known hypersensitivity or contraindications against sodium chlorophyllin.

• Hemodynamically unstable patients not responding to initial resuscitation.

• Patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4).