Clinical Trial

A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.

Study acronym: CHOC-LATE
Not Yet Recruiting Phase 3
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Summary
Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages. The standard treatment for these stages is concurrent chemoradiotherapy, but this can cause long-term side effects such as bladder inflammation, strictures, ulcers, and tissue damage, which negatively impact patients' quality of life. Previous studies have shown that oral sodium-copper-chlorophyllin can help reduce radiation-related side effects in rectal, prostate, and cervical cancer patients. However, no study has compared side effects between patients receiving standard follow-up care and those taking sodium-copper-chlorophyllin during follow-up. We hypothesize that the use of sodium-copper-chlorophyllin as a short-duration adjuvant is associated with reduced incidence of late grade 2 or higher gastrointestinal and genitourinary toxicities compared to patients receiving standard-of-care follow-up.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-09.
Trial Details
NCT Number NCT07164534
Lead Sponsor Tata Memorial Hospital
Conditions Uterine Cervical Neoplasm
Enrollment 316 participants
Start Date 2026-03
Primary Completion 2030-03 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-04