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 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 4603
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

cervix cancer; radiation-related adverse effects; radiation; sodium-copper-chlorophyllin

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence

  Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence, reported using the time-to-event method, taken from the date of random assignment to the occurrence of late toxicity, or death because of late toxicity, at 24 months after completion of RT, by addition of sodium-copper-chlorophyllin for 3 months post RT (starting within 2 weeks of treatment completion), as compared to standard-of-care follow-up.

  24 months

Secondary Outcomes (11)

• Local Control at 24 months

  24 months

• Pelvic Control at 24 months

  24 months

• Nodal Relapse at 24 months

  24 months

• Cumulative C-MOSES score

  24 months

• Proportion of patients with radiotherapy-related urinary stress incontinence

  At treatment completion, 3 months, 6 months, 9 months

Other Outcomes (2)

• Proportion of patients with comorbidities

  At Day 1 and 24 Months

• NRF2 levels

  Day 1, After radiotherapy/before sodium-copper-chlorophyllin, 1 hour after sodium-copper-chlorophyllin, 3 hours after sodium-copper-chlorophyllin, 6 hours after sodium-copper-chlorophyllin

Study Arms (2)

Arm 1: Test arm

EXPERIMENTAL

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

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

Arm 2: Standard

NO INTERVENTION

Standard-of-care follow-up post radiotherapy

Interventions

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

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

Arm 1: Test arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix
• Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.
• Subjects who exceed the dose constraints of:
• Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
• Bladder D 2cm³ EQD2 ³ more than 80 Gy
• Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:
• Haemoglobin: ≥ 8 g/dl
• ANC ≥ 1,500/mm\^3
• Platelet count 100,000/mm\^3
• Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)
• Bilirubin: ≤ 2 x Upper limit of normal (ULN)
• AST and ALT: ≤ 1.5 x ULN
• Subjects willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
• Ability to understand and willingness to sign an informed consent document

You may not qualify if:

• Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation
• Subjects with clinically significant decreased hematologic reserves, with major organ failure, severe electrolyte or metabolic abnormalities, any active infection or any other medical condition that may interfere with the ability to receive study treatment
• HIV positive patients
• Subjects with a history of blood dyscrasias
• Subjects consuming any other concurrent investigational agents
• Subjects with any other previous or current malignancy or RT that is likely to interfere with the protocol treatment, or any other condition which, according to the principal investigator, might make an individual unsuitable for this study
• Subjects participating in any other clinical study within 90 days before enrolment in the study
• Subjects on active anti-coagulant treatment

Sponsors & Collaborators

• Tata Memorial Hospital: lead

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Chlorophyll

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Supriya Sastri, MD

CONTACT

022-68735000; supriyasastri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Supriya Chopra

Model Details: There will be Two Study Arm: If Patient Randomized to Arm 1 (Test arm) they will be given Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily, on an empty stomach for 3 months, starting within 2 weeks of RT completion. If Patient Randomized to Arm 2 (Standard arm) they will receive Standard-of-care follow-up (no intervention) post RT.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 10, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02