Status:
UNKNOWN
Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs
Lead Sponsor:
Tata Memorial Centre
Collaborating Sponsors:
Bhabha Atomic Research Centre (BARC), Mumbai
Conditions:
Hemorrhagic Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.
Detailed Description
Radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. Intensity modulation and image guidance have improved the delivery of radiation...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05348239
Start Date
March 26 2022
End Date
March 31 2024
Last Update
April 27 2022
Active Locations (1)
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1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012