Losartan's effect on chemotherapy-induced mucositis in gastrointestinal cancer patients

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

This study is testing if Losartan can help reduce the mouth and gut soreness caused by chemotherapy in people with gastrointestinal cancers.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ain Shams University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cairo)
• Trial ID: NCT05871333 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of Losartan, an angiotensin 2 receptor blocker, on the incidence and severity of chemotherapy-induced mucositis in patients with gastrointestinal cancers. It involves a controlled trial with two groups: one receiving Losartan and the other a control treatment. Patients will undergo baseline evaluations and weekly assessments to monitor the occurrence and severity of oral and intestinal mucositis, as well as pain levels. The study aims to determine if Losartan can mitigate the adverse effects of chemotherapy on the gastrointestinal tract.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with gastrointestinal cancer who are eligible for chemotherapy.

Not a fit: Patients currently taking ACE inhibitors or ARBs, or those with a history of intolerance to these medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence and severity of mucositis, improving the quality of life and treatment tolerance for patients undergoing chemotherapy.

How similar studies have performed: Previous studies have indicated that angiotensin 2 pathway modulators may have protective effects against mucositis in animal models, suggesting potential for success in human trials.

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.

Where this trial is running

Cairo

• Hospital — Cairo, Egypt (RECRUITING)

Study contacts

• Principal investigator: Amira Y mohamed — Ain Shams University
• Study coordinator: Amira Y Mohamed

Conditions: Chemotherapy, Colorectal Cancer, Intestinal Mucositis, Oral Mucositis, Losartan, Chemotherapy-Induced Mucositis