Clinical trial · Interventional
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)
NCT07164534CI-TRIAL-00102430CHOC-LATEnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts. | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Test arm
- description
- Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily, given on an empty stomach for 3 months, starting within 2 weeks of radiotherapy completion
- interventionNames
- Dietary Supplement: Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.
- type
- NO_INTERVENTION
- label
- Arm 2: Standard
- description
- Standard-of-care follow-up post radiotherapy
Primary outcomes (1)
- measure
- Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (37)
- BACKGROUNDDasgupta A, Sawant S, Chatterjee A, Gota V, Sahu A, Choudhari A, Bhattacharya K, Puranik A, Dev I, Moiyadi A, Shetty P, Singh V, Menon N, Epari S, Sahay A, Shah A, Bano N, Shaikh F, Jirage A, Gupta T. Study Protocol of a Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma (CHROME). Cancer Med. 2025 Mar;14(5):e70657. doi: 10.1002/cam4.70657. PMID 40025673
- BACKGROUNDGagan Prakash DS, Supriya Chopra, Mahendra Pal, Amandeep Arora, Vedang Murthy, Lavanya Gurram, Prachi Mittal, Priyamvada Maitre, Mahendra Joshi, Shiv Madki, Sharath Kumar, Shraddha Bonkar Dethe, Priyal Gawad, Pankaj Chaturvedi, Tapan K Ghanty, Sudeep Gupta, Rajendra A. Badwe, Santosh Sandur, Vikram Gota. A phase II study of oral chlorophyllin in haemorrhagic cystitis secondary to radiation therapy for pelvic malignancies (CLARITY). 2024 ASCO Breakthrough; Yokohama, Japan. J Clin Oncol 42, 2024 (suppl 23; abstr 48): ASCO; 2024
- BACKGROUNDEgner PA, Munoz A, Kensler TW. Chemoprevention with chlorophyllin in individuals exposed to dietary aflatoxin. Mutat Res. 2003 Feb-Mar;523-524:209-16. doi: 10.1016/s0027-5107(02)00337-8. PMID 12628519
- BACKGROUNDSuryavanshi S, Sharma D, Checker R, Thoh M, Gota V, Sandur SK, Sainis KB. Amelioration of radiation-induced hematopoietic syndrome by an antioxidant chlorophyllin through increased stem cell activity and modulation of hematopoiesis. Free Radic Biol Med. 2015 Aug;85:56-70. doi: 10.1016/j.freeradbiomed.2015.04.007. Epub 2015 Apr 11. PMID 25872101
- BACKGROUNDZhang Y, Guan L, Wang X, Wen T, Xing J, Zhao J. Protection of chlorophyllin against oxidative damage by inducing HO-1 and NQO1 expression mediated by PI3K/Akt and Nrf2. Free Radic Res. 2008 Apr;42(4):362-71. doi: 10.1080/10715760801993076. PMID 18404535
- BACKGROUNDKumar SS, Shankar B, Sainis KB. Effect of chlorophyllin against oxidative stress in splenic lymphocytes in vitro and in vivo. Biochim Biophys Acta. 2004 May 3;1672(2):100-11. doi: 10.1016/j.bbagen.2004.03.002.