A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin )… (NCT07164534) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.
316 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 consu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence