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Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia

NCT03254173 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-02-05

No results posted yet for this study

Summary

A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.

Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer receiving mirtazapine 15 mg once daily for 8 weeks \& Arm B will involve another 50 patients with confirmed advanced cancer receiving placebo for 8 weeks.

Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation primarily and to assess other outcomes secondarily which will be discussed later in details.

Conditions

Interventions

DRUG

Mirtazapine 30 mg oral tablets

Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets) , half tablet before sleep for 8 weeks

DRUG

Placebo oral tablets

Placebo oral tablets , half tablet daily before sleep for 8 weeks

Sponsors & Collaborators

  • Catherine Naseef Hunter

    lead OTHER

Principal Investigators

  • Catherine N Hunter, Ass. lecturer · Clinical Oncology Department at Kasr Al Ainy NEMROCK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-10-17
Completion
2019-10-17

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254173 on ClinicalTrials.gov