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

NCT07164534 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasm

Interventions

DIETARY_SUPPLEMENT

Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.

Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily given on an empty stomach for 3 months, starting within 2 weeks of RT completion

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2030-03-31
Completion
2030-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164534 on ClinicalTrials.gov