Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: 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
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
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 with or without chemotherapy with brachytherapy. Subjects who exceed the dose constraints of Rectum or sigmoid D2cm? EQD2? by greater than 70 Gy, or Bladder D2cm? EQD2? 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 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)Timepoint: At 24 month;To Assess Proportion of patients with any acute toxicity At treatment completionTimepoint: For 4 weeks, 8 weeks and 12 weeks after treatment completion.;To Assess Proportion of patients with any haematological abnormalities (anaemia neutropenia thrombocytopenia)Timepoint: At 3 months and 6 months after completion of RT;To Assess Proportion of patients with pre-diabetes diabetes mellitus and hypertensionTimepoint: 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 deficiencyTimepoint: At baseline and annually;To Assess Proportion of patients with RT-related urinary stress incontinence as measured by the Oxford scale at treatment completionTimepoint: For 3 months 6 months and 9 months after completion of RT;Calculated cumulative time and severity incidence of toxicity scores(C-MOSES)Timepoint: At the end of the study and during interim analysis;Patient-reported quality of life using EORTC-QLQ-C30 at baseline and all follow-upsTimepoint: 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 armsTimepoint: At the end of the study and during interim analysis;Levels and profiles of cytokines and NRF2 in all patientsTimepoint: At baseline, after CHL tablet completion,3 months after CHL tablet completion | — |
Countries
India
Contacts
Public ContactDr Supriya Chopra
Tata Memorial Centre
Outcome results
None listed