Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was 8 weeks randomized, double-blind trail to assess the effect of mirtazapine versus megestrol acetate in treatment of anorexia-cachexia in advanced cancer patients in 80 patients. Participants were assessed at baseline, 4 weeks and 8 weeks. Subject were randomized to receive either mirtazapine 15 mg tablet daily or megestrol acetate 160 mg tablet daily for 8 weeks. The primary outcome was the measure of FAACT(A/C) score and the secondary measure includes weight, BMI, quality of life and evaluate adverse effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Megestrol; Megestrol Acetate; Mirtazapine

Criteria

Inclusion Criteria:

• Patients aged ≥ 18 years, with a histologically diagnosed advanced-stage tumor at any site.

• Assumptive or documented loss of >5% of pre-illness or ideal body weight (body mass index) in the previous 3 months.

• Patients could be receiving concomitant chemotherapy, radiotherapy and/or palliative supportive care.

• Patients ECOG Performance Status 0-3.

Exclusion Criteria:

• Patients with a mechanical obstruction to feeding.

• Patients with high doses of corticosteroids.

• Patients with clinically bulky ascites and generalized edema.

• Patients with inability to take oral medications.

• History of uncontrolled diabetes mellitus and hypertension.