Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Jun 23, 2023
  • participants needed
    108
  • sponsor
    Hospital General de Mexico
Updated on 24 March 2022
cancer
inflammatory response

Summary

In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.

Description

Death associated with sepsis is one of the principal complications related to chemotherapy treatment; there are currently no strategies to prevent its development besides the use of prophylactic antibiotics or granulocyte colony stimulants to reduce the period of febrile neutropenia. Most of the trials on the use of statins are retrospective with controversial results and include patients with different clinical situations that conditioned the septic study.

Details
Condition Strains, Acute Lymphoblastic Leukemia, Sepsis
Treatment Simvastatin
Clinical Study IdentifierNCT05133310
SponsorHospital General de Mexico
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with acute leukemia under treatment of a chemotherapy regimen
Stable performance status (ECOG: 0 or Karnofsky scale greater than 80%) at time of analysis and under chemotherapy regimen
Life expectancy greater than 48 hours after diagnosis
Oral route available
Have signed informed consent at the time of the study
Patients whose chemotherapy regimen is administered in a hospital rather than an outpatient manner

Exclusion Criteria

Patients with acute leukemias over 55 years of age and with impaired functional status at the time of diagnosis
Elevation of liver enzymes 3 times higher than the range established by the central laboratory
Persistent kidney involvement despite having adequate hydration
Pregnant patients
Patients with peripheral neuropathy considered severe or disabling grade
Patients with a history of psychiatric disorders or psychotic attacks
Individuals who do not have the oral route available, who are maintained with a nasogastric tube, or who require support for the diagnosis through parenteral nutrition
Patients undergoing peritoneal dialysis or hemodialysis treatment
Patients with leukemia associated with Down syndrome
Patients under low-intensity chemotherapy regimen or palliative regimen
Previous allergy to any statin component
Patients with a history of liver failure (Child-Pugh Stage B or C)
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