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Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

NCT01598584 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-09-28

No results posted yet for this study

Summary

Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Conditions

Interventions

DRUG

Mirtazapine plus gemcitabine

Mirtazapine,15mg/day for 3 days, If patients is durable, the dosage increase to 30mg/day, if the patient is durable, the doctor then will decided whether to increase to 45mg. Gemcitabine 1000mg/M2,d1,d8,q3w

DRUG

Gemcitabine, placebo

Gemcitabine 1.0g/m2,d1,d8,q3w placebo

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Yi Ba, MD, PHD · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

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 NCT01598584 on ClinicalTrials.gov