Neoplasms
Conditions
Interventions
This is a phase IV, randomized, double-blind study in which neither the participant nor the researcher will identify the group with placebo and neither the group with medication, in this case omeprazo
Sponsors
UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE
Liga Norte Riograndense Contra o Câncer
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years; Starting chemotherapy with a regime containing cisplatin, carboplatin or oxaliplatin; Chemotherapy regimen of 1 day or 5 consecutive days; Agree to participate by signing the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Not having moderate to severe kidney disease or advanced disease with a life expectancy of less than 6 months; Having no history of hypersensitivity to any of the components of the omeprazole or placebo formulation; You must not have concomitant therapy with warfarin, atazanavir, tacrolimus or voriconazole; Patients taking diazepam, phenytoin or ampicillin may be included but the doses of these drugs should be adjusted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find serum and total magnesium variations between the platinum groups associated with omeprazole compared to the placebo-associated platinum group and to identify possible neuropathic reactions using the Common Terminology Criteria for Adverse Events (CTCAE) severity rating - version 5.0 caused by magnesium deficiency | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate other correlations related to loss of magnesium or use of omeprazole, such as: Anemia and renal failure through the levels of creatinine and urea, benefit of using omeprazole in preventing gastrointestinal effects, as well as possible control measures and serum monitoring of magnesium medium and long term when possible | — |
Countries
Brazil
Contacts
Public ContactFernanda Raffin
Outcome results
None listed