Effect of Losartan on the Incidence and Severity of Chemotherapy-Induced Mucositis in Gastrointestinal Cancer Patients

Launched by AIN SHAMS UNIVERSITY · May 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Losartan on a side effect known as mucositis, which can occur in patients receiving chemotherapy for gastrointestinal cancers, like colorectal cancer. Mucositis can cause painful inflammation and ulcers in the mouth and other parts of the digestive system, making it difficult for patients to eat and tolerate their cancer treatment. The researchers want to see if Losartan can help reduce the occurrence and severity of this condition.

To participate in the trial, patients need to be at least 18 years old and diagnosed with gastrointestinal cancer that requires chemotherapy. They should be in reasonably good health, meaning they can carry out everyday activities with some assistance. However, individuals currently taking certain medications or with specific health issues, like severe kidney disease or low blood pressure, cannot join. Participants will receive treatment and will be monitored to see how well Losartan works in preventing mucositis. This trial is important because finding effective ways to manage mucositis can improve the quality of life for cancer patients undergoing treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged 18 years old or more.
• • 2. Patients diagnosed with gastrointestinal cancer eligible for chemotherapy
• • 3. Eastern Cooperative Oncology Group (ECOG) performance ≤ 2.
• • 4. Platelet count more than 100 × 10\^9/L.
• • 5. Absolute neutrophil count: greater than 1.5 × 10\^9/L.
• • 6. Aspartate aminotransferase level up to 2.5 times the upper limit normal.
• • 7. Serum bilirubin level not more than 1.5 times the institutional upper limit normal.
• • 8. Serum creatinine levels up to 1.5 mg% and 1.4 mg% for males and females respectively.
• Exclusion Criteria:
• • 1. Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
• • 2. Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema.
• • 3. Pregnant or breastfeeding women.
• • 4. Females in child bearing age not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception.
• 5. Patient reported history or electronic medical record history of kidney disease, defined as:
• • Any history of dialysis. History of chronic kidney disease stage IV. Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 Other Kidney disease that in the opinion of investigator, would affect Losartan Clearance.
• • 6. Patient reported dehydration and significantly decreased urine output in the past 72 hours.
• • 7. Most recent systolic blood pressure prior to enrollment \<110 mmHg.
• • 8. Current participation in any other clinical investigation.
• • 9. Currently taking any drug contraindicated with Losartan administration.