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.
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.
Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
Bladder D 2cm³ EQD2 ³ more than 80 Gy
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
Parallel
Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.
Dietary supplementOral adjuvant sodium-copper-chlorophyllin 750mg given once daily given on an empty stomach for 3 months, starting within 2 weeks of RT completion
Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence
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.
Local Control at 24 months
Local Control: defined as the time interval between the date of random assignment and first evidence of local relapse.
Pelvic Control at 24 months
Pelvic Control: defined as the time interval between the dates of random assignment and first evidence of local and pelvic relapse
Nodal Relapse at 24 months
Nodal Control: defined as the time interval between the dates of random assignment and first evidence of any regional nodal relapse
Cumulative C-MOSES score
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
Proportion of patients with comorbidities
Proportion of patients with pre-diabetes, diabetes mellitus and hypertension at baseline and follow-up
NRF2 levels
Levels of NRF2 in all patients
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