CTRI

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CTRI Number

CTRI/2025/09/094294 [Registered on: 04/09/2025] Trial Registered Prospectively

Last Modified On:

03/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A clinical study exploring whether an oral medication called sodium copper chlorophyllin, can activate bodys natural protective system NRF2 and can help women with locally advanced cervical cancer experience fewer long term side effects after undergoing radiotherapy

Scientific Title of Study

A Phase III trial to assess the effectiveness of NRF2 activator (oral sodium-copper- chlorophyllin ) in locally advanced cervical cancer to reduce late radiotherapy toxicity.

Trial Acronym

CHOC-LATE

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Supriya Chopra
Designation	Professor Radiation Oncology
Affiliation	Tata Memorial Centre
Address	PS-246 Department of Radiation Oncology Tata Memorial Hospital Sector 22 Kharghar Navi Mumbai Raigarh MAHARASHTRA 410210 India
Phone	9930958309
Fax
Email	schopra@actrec.gov.in

Details of Contact Person
Scientific Query

Name	Dr Supriya Chopra
Designation	Professor Radiation Oncology
Affiliation	Tata Memorial Centre
Address	PS-246 Department of Radiation Oncology Tata Memorial Hospital Sector 22 Kharghar Navi Mumbai Raigarh MAHARASHTRA 410210 India
Phone	9930958309
Fax
Email	schopra@actrec.gov.in

Details of Contact Person
Public Query

Name	Dr Supriya Chopra
Designation	Professor Radiation Oncology
Affiliation	Tata Memorial Centre
Address	PS-246 Department of Radiation Oncology Tata Memorial Hospital Sector 22 Kharghar Navi Mumbai Raigarh MAHARASHTRA 410210 India
Phone	9930958309
Fax
Email	schopra@actrec.gov.in

Source of Monetary or Material Support

Tata Memorial Centre Research Administration Council (TRAC), Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai, Maharashtra, India 400012

Primary Sponsor

Name	Tata Memorial Hospital
Address	Dr. E Borges Road, Parel, Mumbai -400012
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Supriya Chopra	ACTREC, Tata Memorial Centre	PS246, Department of Radiation Oncology, Actrec Tata Memorial Hospital Sector 22 Kharghar Raigarh MAHARASHTRA	9930958309 schopra@actrec.gov.in
Dr Supriya Chopra	Tata Memorial Hospital	OPD- 61, Ground Floor,Homi Bhabha Building, Dr.Ernest Borges Road,Parel, Mumbai- 400012 Mumbai MAHARASHTRA	9930958309 schopra@actrec.gov.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee II, Tata Memorial Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C539\|\|Malignant neoplasm of cervix uteri, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	In the control arm, patient will only receive standard-of-care treatment i.e. concurrent chemoradiotherapy for cervical cancer.
Intervention	Sodium-Copper-Chlorophyllin	In the experimental arm, in addition to standard-of-care follow-up, patients will receive oral sodium-copper-chlorophyllin at a dose of 750mg once daily (od) in the morning on an empty stomach for three months, starting at treatment completion and initiated not later than 2 weeks of treatment completion.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Female
Details	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 with or without chemotherapy with brachytherapy. Subjects who exceed the dose constraints of Rectum or sigmoid D2cm³ EQD2³ by greater than 70 Gy, or Bladder D2cm³ EQD2³ greater than 80 Gy. Subjects with adequate haematological renal hepatic and coagulation profiles and laboratory parameters within the following ranges Haemoglobin greater than or equal to 8 g per dl ANC greater than or equal to 1500mm3 Platelet count 100,000 mm3 Creatinine Clearance greater than or equal 50 ml min as per Cockcroft-Gault formula Bilirubin less than or equal to 2 multiplied by Upper limit of normal ULN AST and ALT less than or equal 1.5 multiplied by ULN. Subjects willing and able to comply with all study requirements, including treatment example able to swallow tablets timing and or nature of required assessment. Ability to understand and willing to sign an informed consent document.

ExclusionCriteria

Details

Subjects with known hypersensitivity or contraindication to study drug or to any known component of 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

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome

TimePoints

Proportion of patients with cumulative late grade 2 or higher RT-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.

Patients will be assessed at 3-month intervals for 24 month.
for late grade 2 or higher RT-related gastrointestinal and genitourinary toxicities and any other changes.

Secondary Outcome

Outcome	TimePoints
Local Control, Pelvic Control Nodal Relapse Disease-Free Survival and Overall Survival (Patients not experiencing any event or patients who are alive up to the time of analysis will be censored on the date of the last follow-up)	At 24 month
To Assess Proportion of patients with any acute toxicity At treatment completion	For 4 weeks, 8 weeks and 12 weeks after treatment completion.
To Assess Proportion of patients with any haematological abnormalities (anaemia neutropenia thrombocytopenia)	At 3 months and 6 months after completion of RT
To Assess Proportion of patients with pre-diabetes diabetes mellitus and hypertension	At baseline and follow up
To Assess Proportion of patients with poor bone health as measured by DEXA scan vitamin B12 deficiency and vitamin D deficiency	At baseline and annually
To Assess Proportion of patients with RT-related urinary stress incontinence as measured by the Oxford scale at treatment completion	For 3 months 6 months and 9 months after completion of RT
Calculated cumulative time and severity incidence of toxicity scores(C-MOSES)	At the end of the study and during interim analysis
Patient-reported quality of life using EORTC-QLQ-C30 at baseline and all follow-ups	At 3, 6, 9, 12, 15, 18, 21 and 24 months after RT completion
Cost (in INR) of management of treatment-related toxicity in both arms	At the end of the study and during interim analysis
Levels and profiles of cytokines and NRF2 in all patients	At baseline, after CHL tablet completion,3 months after CHL tablet completion

Target Sample Size

Total Sample Size="316"
Sample Size from India="316"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

01/10/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="5"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

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.