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Trial Title:
Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
NCT ID:
NCT05789797
Condition:
Cancer
Drug Induced Liver Injury
Conditions: Official terms:
Chemical and Drug Induced Liver Injury
Wounds and Injuries
Conditions: Keywords:
cancer
drug induced liver injury
remaxol
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Remaxol
Description:
Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day,
on everyday basis for 12 days
Arm group label:
The test group
Summary:
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.
Criteria for eligibility:
Study pop:
Cancer patients with drug-induced liver injuries, during antitumor therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- The study can include all patients who are scheduled, at a physician's discretion,
to receive the therapy with the drug Remaxol®, solution for infusions, or
Ademethionine, lyophilizate for solution for intravenous and intramuscular
injection, according to the approved instruction for the medical use of the drug and
established clinical practice of a healthcare facility, and who meet all the
following criteria:
1. Males and females aged from 40 to 70 years inclusive.
2. Verified diagnosis of neoplasm (morphologically proven).
3. Receiving the course polychemotherapy (PCT).
4. PCT regimens with pronounced hepatotoxic effects, which use drugs from the
following pharmacologic classes:
1. Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
2. Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
3. Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
4. Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
5. Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
1. Contraindications for the continuation of PCT at the time of a visit to a
physician for its continuation, because of developed hepatotoxicity.
2. Stage of the treatment: supporting, hepatoprotective and detoxication therapy
to correct hepatotoxicity developed during PCT, to remove it and continue the
chemotherapeutic treatment.
3. A patient is scheduled to receive one of the following infusion therapies with
the following regimen, as part of the routine clinical practice:
4. It is planned to administer the drug Remaxol®, solution for infusions, by
intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12
days.
5. It is planned to administer the drug Ademethionine, lyophilisate for solution
for intravenous and intramuscular injection, by intravenous drop infusion in
the dose of 800 mg/day, on everyday basis for 14 days. ECOG performance status
score: 1-2 inclusive (Karnofsky score: 50-80 %).
6. Hepatotoxicity grade according to the classification of the US National Cancer
Institute (NCCN, CTC) - 2 and 3.
7. Scores by selected parameters of CTCAE (National Cancer Institute Common
Toxicity Criteria for Adverse Events) scale - I and II.
8. Patient's written consent for participation in the study according to the
current legislation.
Exclusion Criteria:
1. Pregnancy, breast-feeding.
2. Mental disorders requiring psychiatric observation.
3. Chronic alcohol abuse and/or substance abuse.
4. HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases,
tuberculosis.
5. Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT
session immediately preceding this study.
6. Administration of methionine-, Ademetionine-, malate- and/or succinate-containing
medicines during the last month.
7. Prescription of other malate-, succinate, or methionine-containing medicines
(mexidol, cytoflavin, etc.).
8. Decompensation of any severe/clinically apparent somatic diseases of the kidneys,
liver, cardiovascular system, respiratory system, endocrine system, etc., as decided
by the investigating physician.
9. Contraindications mentioned in the approved instructions for use of medicines
applied in the study (idiosyncrasy to the product components).
10. Disease or use of medicines, which, in the doctor's opinion, can influence safety,
tolerability and efficiency of the study medicines.
Gender:
All
Minimum age:
40 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
State Budget-Funded Health Institution Kryzhanovsky Krasnoyarsk Krai Clinical Cancer Centre
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
North-West Center of Evidence-Based Medicine
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Pirogov Clinic of High Medical Technologies, St. Petersburg State University
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
St. Petersburg State Budget-Funded Health Institution City Clinical Cancer Centre
Address:
City:
St. Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Republican Clinical Cancer Centre
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Start date:
May 12, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
POLYSAN Scientific & Technological Pharmaceutical Company
Agency class:
Industry
Source:
POLYSAN Scientific & Technological Pharmaceutical Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789797
