Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT07164534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002734', 'term': 'Chlorophyll'}], 'ancestors': [{'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be Two Study Arm:\n\nIf 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients with comorbidities', 'timeFrame': 'At Day 1 and 24 Months', 'description': 'Proportion of patients with pre-diabetes, diabetes mellitus and hypertension at baseline and follow-up'}, {'measure': 'NRF2 levels', 'timeFrame': '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', 'description': 'Levels of NRF2 in all patients'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence', 'timeFrame': '24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Local Control at 24 months', 'timeFrame': '24 months', 'description': 'Local Control: defined as the time interval between the date of random assignment and first evidence of local relapse.'}, {'measure': 'Pelvic Control at 24 months', 'timeFrame': '24 months', 'description': 'Pelvic Control: defined as the time interval between the dates of random assignment and first evidence of local and pelvic relapse'}, {'measure': 'Nodal Relapse at 24 months', 'timeFrame': '24 months', 'description': 'Nodal Control: defined as the time interval between the dates of random assignment and first evidence of any regional nodal relapse'}, {'measure': 'Cumulative C-MOSES score', 'timeFrame': '24 months', 'description': 'Cumulative time and severity incidence of toxicity scores (Months and Severity Score (MOSES) C-MOSES) for each patient, which is a toxicity summarising method that incorporates time'}, {'measure': 'Proportion of patients with radiotherapy-related urinary stress incontinence', 'timeFrame': 'At treatment completion, 3 months, 6 months, 9 months', 'description': 'Proportion of patients with RT-related urinary stress incontinence, as measured by the Oxford scale at treatment completion, 3 months, 6 months and 9 months after completion of RT'}, {'measure': 'Disease-Free Survival at 24 months', 'timeFrame': '24 months', 'description': 'Disease-Free Survival: defined as the time interval between date of random assignment and first relapse or death because of any cause.'}, {'measure': 'Overall Survival at 24 months', 'timeFrame': '24 months', 'description': 'Overall Survival: defined as the time interval between the date of random assignment and death due to any cause.'}, {'measure': 'Proportion of patients with any acute toxicity', 'timeFrame': '4 weeks, 8 weeks and 12 weeks post radiotherapy completion', 'description': 'Proportion of patients with any acute toxicity at treatment completion, 4 weeks, 8 weeks and 12 weeks after treatment completion.'}, {'measure': 'Proportion of patients with any haematological abnormalities', 'timeFrame': '3 months and 6 months post radiotherapy completion', 'description': 'Proportion of patients with any haematological abnormalities (anaemia, neutropenia, thrombocytopenia) at 3 months and 6 months after completion of RT'}, {'measure': 'Patient-reported quality of life (QoL)', 'timeFrame': '3, 6, 9, 12, 15, 18, 21 and 24 months after radiotherapy completion', 'description': 'Patient-reported quality of life (QoL) using EORTC-QLQ-C30 at baseline and all follow-ups'}, {'measure': 'Cost of management of radiotherapy-related toxicity', 'timeFrame': '24 months', 'description': 'Cost (in INR) of management of treatment-related toxicity in both arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervix cancer', 'radiation-related adverse effects', 'radiation', 'sodium-copper-chlorophyllin'], 'conditions': ['Uterine Cervical Neoplasm']}, 'referencesModule': {'references': [{'pmid': '40025673', 'type': 'BACKGROUND', 'citation': 'Dasgupta 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.'}, {'type': 'BACKGROUND', 'citation': 'Gagan 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'}, {'pmid': '12628519', 'type': 'BACKGROUND', 'citation': 'Egner PA, Munoz A, Kensler TW. Chemoprevention with chlorophyllin in individuals exposed to dietary aflatoxin. 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Biochim Biophys Acta. 2004 May 3;1672(2):100-11. doi: 10.1016/j.bbagen.2004.03.002.'}, {'pmid': '14644357', 'type': 'BACKGROUND', 'citation': 'Park KK, Park JH, Jung YJ, Chung WY. Inhibitory effects of chlorophyllin, hemin and tetrakis(4-benzoic acid)porphyrin on oxidative DNA damage and mouse skin inflammation induced by 12-O-tetradecanoylphorbol-13-acetate as a possible anti-tumor promoting mechanism. Mutat Res. 2003 Dec 9;542(1-2):89-97. doi: 10.1016/j.mrgentox.2003.09.001.'}, {'pmid': '11767414', 'type': 'BACKGROUND', 'citation': 'Kumar SS, Devasagayam TP, Bhushan B, Verma NC. Scavenging of reactive oxygen species by chlorophyllin: an ESR study. Free Radic Res. 2001 Nov;35(5):563-74. doi: 10.1080/10715760100301571.'}, {'pmid': '26091384', 'type': 'BACKGROUND', 'citation': 'Stephens TJ, McCook JP, Herndon JH Jr. Pilot Study of Topical Copper Chlorophyllin Complex in Subjects With Facial Acne and Large Pores. 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Epub 2015 Dec 29.'}, {'pmid': '32853710', 'type': 'BACKGROUND', 'citation': 'Vittrup AS, Tanderup K, Bentzen SM, Jensen NBK, Spampinato S, Fokdal LU, Lindegaard JC, Sturdza A, Schmid M, Segedin B, Jurgenliemk-Schulz IM, Bruheim K, Mahantshetty U, Haie-Meder C, Rai B, Cooper R, van der Steen-Banasik E, Sundset M, Huang F, Nout RA, Villafranca E, Van Limbergen E, Pieters BR, Tan LT, Lutgens LCHW, Hoskin P, Potter R, Kirchheiner K; EMBRACE Collaborative Group. Persistence of Late Substantial Patient-Reported Symptoms (LAPERS) After Radiochemotherapy Including Image Guided Adaptive Brachytherapy for Locally Advanced Cervical Cancer: A Report From the EMBRACE Study. Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):161-173. doi: 10.1016/j.ijrobp.2020.08.044. Epub 2020 Aug 25.'}, {'pmid': '21998757', 'type': 'BACKGROUND', 'citation': 'Berveling MJ, Langendijk JA, Beukema JC, Mourits MJ, Reyners AK, Pras E. 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Epub 2020 Oct 14.'}, {'pmid': '21345618', 'type': 'BACKGROUND', 'citation': 'Georg P, Potter R, Georg D, Lang S, Dimopoulos JC, Sturdza AE, Berger D, Kirisits C, Dorr W. Dose effect relationship for late side effects of the rectum and urinary bladder in magnetic resonance image-guided adaptive cervix cancer brachytherapy. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):653-7. doi: 10.1016/j.ijrobp.2010.12.029. Epub 2011 Feb 23.'}, {'pmid': '34678431', 'type': 'BACKGROUND', 'citation': 'Spampinato S, Jensen NBK, Potter R, Fokdal LU, Chargari C, Lindegaard JC, Schmid MP, Sturdza A, Jurgenliemk-Schulz IM, Mahantshetty U, Hoskin P, Segedin B, Rai B, Bruheim K, Wiebe E, Van der Steen-Banasik E, Cooper R, Van Limbergen E, Sundset M, Pieters BR, Lutgens LCHW, Tan LT, Villafranca E, Smet S, Jastaniyah N, Nout RA, Kirisits C, Chopra S, Kirchheiner K, Tanderup K, Embrace Collaborative Group. 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Epub 2018 Feb 12.'}, {'pmid': '29423520', 'type': 'BACKGROUND', 'citation': 'Shrivastava S, Mahantshetty U, Engineer R, Chopra S, Hawaldar R, Hande V, Kerkar RA, Maheshwari A, Shylasree TS, Ghosh J, Bajpai J, Gurram L, Gulia S, Gupta S; Gynecologic Disease Management Group. Cisplatin Chemoradiotherapy vs Radiotherapy in FIGO Stage IIIB Squamous Cell Carcinoma of the Uterine Cervix: A Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):506-513. doi: 10.1001/jamaoncol.2017.5179.'}, {'pmid': '30147092', 'type': 'BACKGROUND', 'citation': 'Chopra S, Gupta M, Mathew A, Mahantshetty U, Engineer R, Lavanya G, Gupta S, Ghosh J, Thakur M, Deodhar K, Menon S, Rekhi B, Bajpai J, Gulia S, Maheshwari A, Kerkar R, Shylasree TS, Shrivastava SK. Locally advanced cervical cancer: A study of 5-year outcomes. Indian J Cancer. 2018 Jan-Mar;55(1):45-49. doi: 10.4103/ijc.IJC_428_17.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}]}, 'descriptionModule': {'briefSummary': "Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages.\n\nThe 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.\n\nPrevious 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.\n\nWe 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.", 'detailedDescription': "Descriptive summary\n\nObjectives\n\nPrimary objective\n\n• To assess the effectiveness of adjuvant sodium-copper-chlorophyllin in reducing the cumulative incidence of late grade 2 or higher RT-related gastrointestinal and genitourinary toxicity in cervix cancer patients, measured using the time-to-event method\n\nSecondary objectives\n\n* To evaluate the effect of sodium-copper-chlorophyllin tablet administration on 24-month local control, pelvic control, nodal relapse, disease-free survival, overall survival\n* To compare the effect of sodium-copper-chlorophyllin on haematological parameters (persistent anaemia, neutropenia, thrombocytopenia)\n* To compare the number of patients with RT-related urinary stress incontinence\n* To examine the effect of diabetes mellitus, hypertension, bone health and vitamin deficiencies on the occurrence and recovery from RT-related toxicity\n* To calculate cumulative time- and severity-related toxicity scores (C-MOSES scores)\n* To compare prevalence of cystoscopic and sigmopidoscopy changes in test and standard arms and clinical symptoms in relation to the findings.\n* To evaluate the quality of life in both arms\n* To compare time spent in toxicity\n* To calculate direct financial costs of adverse event management and impact on health care system.\n* To investigate the effect of sodium-copper-chlorophyllin on the immune cell profile and oxidative stress markers of patients\n\nTrial Design\n\nThis is a parallel-arm, randomized Phase III trial designed to test whether oral sodium-copper-chlorophyllin can reduce late (grade 2 or higher) gastrointestinal and genitourinary toxicities 24 months after completion of radiotherapy (RT) in cervical cancer patients.\n\nSample Size\n\nTotal of 316 patients will need to be randomized to the two arms in a 2:1 ratio (210 in the treatment group and 106 in the control group), accounting for an estimated 10%loss to follow-up. This sample size calculation was conducted using RPACT Package of R software.\n\nArm 1 (Test arm): Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily, on an empty stomach for 3 months, starting within 2 weeks of RT completion\n\nArm 2 (Standard arm): Standard-of-care follow-up (no intervention) post RT\n\nPatient will be selected as per Inclusion \\& Exclusion Criteria.\n\nInclusion criteria\n\n* Female subjects aged 18 years or above with histologically proven locally advanced\n* squamous cell or adenocarcinoma of the cervix\n* Subjects eligible for RT and planned for definitive RT +/- chemotherapy with\n* brachytherapy.\n* Subjects who exceed the dose constraints of:\n\n * Rectum/sigmoid D2cm3 EQD23 by \\>70 Gy, or\n * Bladder D2cm3 EQD23 \\>80 Gy\n* Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:\n\n * Haemoglobin: ≥ 8 g/dl\n * ANC ≥ 1,500/mm\\^3\n * Platelet count 100,000/mm\\^3\n * Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)\n * Bilirubin: ≤ 2 x Upper limit of normal (ULN)\n * AST and ALT: ≤ 1.5 x ULN\n* 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\n* Ability to understand and willing to sign an informed consent document\n\nExclusion criteria\n\n* Subjects with known hypersensitivity or contraindication to study drug or to any known component of study drug formulation\n* 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\n* HIV positive patients\n* Subjects with a history of blood dyscrasias\n* Subjects consuming any other concurrent investigational agents\n* 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\n* Subjects participating in any other clinical study within 90 days before enrolment in the study\n* Subjects on active anti-coagulant treatment\n\nStudy Procedure\n\n* All patients will have a baseline MRI or CT of the abdomen and pelvis.\n* Concurrent chemoradiation and image-guided brachytherapy will be administered as per standard of care.\n* Similarly, follow-up will be as per standard of care.\n* During RT, patients will be evaluated weekly by investigators, and toxicities will be recorded using CTCAE v5.0 guidelines.\n* Patients in the test arm will receive sodium-copper-chlorophyllin tablets (750 mg) once daily for 3 months, starting within 2 weeks of RT completion. Thus, a patient will take a total of 90 tablets. Sufficient tablets will be dispensed to the patient at each follow-up to last until the subsequent follow-up.\n* Compliance to sodium-copper-chlorophyllin will be checked weekly by the study PI and study staff and through a patient drug logbook.\n* The number of patients who do not complete the sodium-copper-chlorophyllin regimen will be noted, along with the reason for non-compliance.\n* At the first follow-up, all patients will undergo clinical examination, blood collection and weight documentation.\n* Radiological Examination will be done as per protocol.\n* Patients will be followed post-completion of RT at 1 week for assessment of toxicity.\n* Patients will be assessed at 3-month intervals for 2 years.\n* for late grade ≥2 RT-related gastrointestinal and genitourinary toxicities and any other changes,\n* Cystoscopies and sigmoidoscopies will be done.\n* Cystoscopy and sigmoidoscopy will be performed twice a year for all patients.\n\nCriteria for Adverse events\n\nIf there is suspicion of disease relapse, treatment will be given at the investigator's discretion.\n\nAny grade 2 or higher nausea, vomiting or other sodium-copper-chlorophyllin-related adverse events will be reported in the case report forms. If any of the above adverse events lead to admission, serious adverse events (SAEs) will be reported to the IEC.\n\nStatistical Plan\n\nIn this study, exploratory descriptive analyses and statistical analyses tests such as Kaplan-Meier, Chi-Square, Fisher's analysis and ANOVA will be conducted.\n\nBaseline characteristics of patients in both study arms will be summarized using means and standard deviations for continuous variables and counts and percentages for categorical variables.\n\nThe primary efficacy endpoint will be assessed using Kaplan Meier Analysis using two-sided log rank test.\n\nSecondary analyses will include logistic regression to adjust for confounders such as age and cancer stage with subgroup analyses based on HR-CTV and other relevant factors.\n\nTime-to-toxicity will be evaluated using Kaplan-Meier survival analysis and log-rank tests for 2- and 3-year outcomes. Haematological parameters will be compared using Chi-Square or Fisher's exact tests.\n\nChanges in Quality of Life (QOL) scores over a 2-year follow-up will be assessed using linear mixed modelling.\n\nAverage costs per grade of toxicity and according to arm of the study will be calculated. An Analysis of Variance (ANOVA) test will be considered to determine if there is a difference in costs between grades of toxicity, and an independent sample t-test will be used to determine if the average cost according to study arm is significantly different. The costs of study related additional cystoscopy and sigmoidoscopy are not included.\n\nAll analyses will be conducted using SPSS version 28, with a significance level set at 0.05.\n\nInterim and full analyses will be performed.\n\nAnticipated benefits of this study\n\nIf the trial results are positive, using adjuvant sodium-copper-chlorophyllin could potentially lower the incidence of late-grade toxicity associated with RT by 10% for cervical cancer.\n\nThis has the potential to improve the long-term quality of life for patients and reduce the costs associated with managing treatment-related side effects for both the healthcare system and patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix\n* Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.\n* Subjects who exceed the dose constraints of:\n\n * Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or\n * Bladder D 2cm³ EQD2 ³ more than 80 Gy\n* Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:\n\n * Haemoglobin: ≥ 8 g/dl\n * ANC ≥ 1,500/mm\\^3\n * Platelet count 100,000/mm\\^3\n * Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)\n * Bilirubin: ≤ 2 x Upper limit of normal (ULN)\n * AST and ALT: ≤ 1.5 x ULN\n* 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\n* Ability to understand and willingness to sign an informed consent document\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation\n* 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\n* HIV positive patients\n* Subjects with a history of blood dyscrasias\n* Subjects consuming any other concurrent investigational agents\n* 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\n* Subjects participating in any other clinical study within 90 days before enrolment in the study\n* Subjects on active anti-coagulant treatment'}, 'identificationModule': {'nctId': 'NCT07164534', 'acronym': 'CHOC-LATE', 'briefTitle': 'A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tata Memorial Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '4603'}}, 'armsInterventionsModule': {'armGroups': [{'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'}], 'interventions': [{'name': 'Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily given on an empty stomach for 3 months, starting within 2 weeks of RT completion', 'armGroupLabels': ['Arm 1: Test arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Supriya Sastri, MD', 'role': 'CONTACT', 'email': 'supriyasastri@gmail.com', 'phone': '022-68735000', 'phoneExt': '5113'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Supriya Chopra', 'investigatorFullName': 'Supriya Sastri (chopra)', 'investigatorAffiliation': 'Tata Memorial Hospital'}}}}