Using Remaxol to treat liver injuries caused by cancer chemotherapy

Non-interventional, Prospective Study of Safety and Efficiency of the Drug Remaxol® (NTFF POLYSAN Ltd., Russia) in Patients with Drug-induced Liver Injuries During Cancer Chemotherapy.

This study tests if Remaxol can help people aged 40 to 70 who have liver injuries from cancer chemotherapy feel better and protect their liver during treatment.

Quick facts

• Study type: Observational
• Enrollment: 368 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (Industry-sponsored)
• Drugs / interventions: Methotrexate, Cyclophosphamide, Doxorubicin
• Locations: 5 sites (Krasnoyarsk and 4 other locations)
• Trial ID: NCT05789797 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effects of Remaxol in patients experiencing drug-induced liver injuries during cancer chemotherapy. It aims to include patients aged 40 to 70 who are undergoing polychemotherapy with known hepatotoxic agents. The study will assess the safety and efficacy of Remaxol in mitigating liver damage associated with these treatments. Participants will be monitored for liver function and overall health outcomes throughout the chemotherapy regimen.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 40 to 70 with a verified diagnosis of cancer who are receiving hepatotoxic chemotherapy.

Not a fit: Patients outside the age range of 40 to 70 or those not undergoing chemotherapy with hepatotoxic drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to protect liver function in cancer patients undergoing chemotherapy.

How similar studies have performed: While there is limited information on similar studies, the approach of using hepatoprotective agents during chemotherapy has shown promise in other contexts.

Eligibility 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.).

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  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.

Where this trial is running

Krasnoyarsk and 4 other locations

• State Budget-Funded Health Institution Kryzhanovsky Krasnoyarsk Krai Clinical Cancer Centre — Krasnoyarsk, Russian Federation (Recruiting)
• North-West Center of Evidence-Based Medicine — Saint Petersburg, Russian Federation (Recruiting)
• Pirogov Clinic of High Medical Technologies, St. Petersburg State University — Saint Petersburg, Russian Federation (Recruiting)
• St. Petersburg State Budget-Funded Health Institution City Clinical Cancer Centre — St. Petersburg, Russian Federation (Recruiting)
• Republican Clinical Cancer Centre — Ufa, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Alexey Kovalenko, Doc Biol Sci

Conditions Cancer; Drug Induced Liver Injury; cancer; drug induced liver injury; remaxol