Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality. 40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.
Study Type
OBSERVATIONAL
Enrollment
368
Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days
State Budget-Funded Health Institution Kryzhanovsky Krasnoyarsk Krai Clinical Cancer Centre
Krasnoyarsk, Russia
North-West Center of Evidence-Based Medicine
Saint Petersburg, Russia
Pirogov Clinic of High Medical Technologies, St. Petersburg State University
Saint Petersburg, Russia
St. Petersburg State Budget-Funded Health Institution City Clinical Cancer Centre
Saint Petersburg, Russia
Difference of average ALT values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Time frame: Baseline, up to 15 days
Difference of average ALP values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Time frame: Baseline, up to 15 days
Proportion of patients achieving an ECOG patient status score of 0 from the start of study (Visit1) to Visit 4, measured in both groups
ECOG Scale of Performance Status (Eastern Cooperative Oncology Group) - 0-4 poins 0 points - The patient is fully active, able to perform everything, as before the disease. 4 points - Disabled, completely incapable of self-care, chained to a chair or bed
Time frame: Baseline, up to 28 days
Proportion of patients who resumed a PCT session (staged session after a period of study medicines administration) within 28 days of the start of hepatotoxicity correction with study medicines (Visit 1), measured in both groups.
Time frame: Baseline, up to 28 days
Proportion of patients who received a staged PCT session in full (no reduction in chemotherapy doses), measured in both groups.
Time frame: Baseline, up to 28 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 15 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 4, measured in both groups.
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Republican Clinical Cancer Centre
Ufa, Russia
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 28 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 15 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 4, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 28 days
Difference of average total scores in A.V. Shaposhnikov hepatotoxicity scale measured in both groups between two time points: Visit 3 vs. baseline at Visit 1 (before the therapy with study medicines).
0 degree = 0-3 points; 1 degree = 3-8 points; 2 degree = 9-14 points; 3rd degree = 15-20 points; 4 degree = 21-25 points.
Time frame: Baseline, up to 15 days
ALT changes during the study period (Visit 2, 3, 4)
Time frame: Baseline, up to 15 days, up to 28 days
Proportion of patients achieving 90% or more on the Karnofsky scale from the start of the study (Visit 1) to Visit 3, measured in both groups.
the Karnofsky score: 100% - Normal condition, no complaints 90% - Capable of normal activities, minor symptoms or signs of disease 80% - Normal activity with effort, minor symptoms or signs of disease 70% Self-supporting, incapable of normal activities or active work 60% - Sometimes needs help, but is able to satisfy most of his needs. 50% - Needs significant assistance and medical care 40% - Disabled, needs special assistance, including medical 30% - Severe disability, hospitalization is indicated, although death is not directly threatened 20% - Severe patient. Hospitalization and active treatment required 10% - Dying
Time frame: Baseline, up to 15 days
Proportion of patients with full normalisation of ALT, AST by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of ALP by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of GGT by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of total and direct bilirubin by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the Karnofsky score during the study (Visits 2, 3, 4) compared to the study initiation (Visit 1), expressed as a % of the baseline
the Karnofsky score: 100% - Normal condition, no complaints 90% - Capable of normal activities, minor symptoms or signs of disease 80% - Normal activity with effort, minor symptoms or signs of disease 70% Self-supporting, incapable of normal activities or active work 60% - Sometimes needs help, but is able to satisfy most of his needs. 50% - Needs significant assistance and medical care 40% - Disabled, needs special assistance, including medical 30% - Severe disability, hospitalization is indicated, although death is not directly threatened 20% - Severe patient. Hospitalization and active treatment required 10% - Dying
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the ECOG Scale, during the study period (Visits 2, 3, 4) as compared to the study initiation (Visit 1), expressed as a score and as a % of the baseline
ECOG Scale of Performance Status (Eastern Cooperative Oncology Group) - 0-4 poins 0 points - The patient is fully active, able to perform everything, as before the disease. 4 points - Disabled, completely incapable of self-care, chained to a chair or bed
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 15 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 4, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 28 days