NCT07164534Not 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.
A Phase III Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity. (CHOC-LATE Trial)
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- First submitted
- 1 Sept 2025
- Start date
- Mar 2026
- Primary completion date
- Mar 2030
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07164534
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 316
- From Mar 2026 to the primary completion date, Mar 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Subjects on active anti-coagulant treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.