Pancreatic Cancer Clinical Trial
Official title:
A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
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.
The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with
gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients
for each arm after randomization.
The inclusion criteria included:
1. Patients shall have normal organic function such as liver function, Cardiac function
and renal function.
2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree
of depression and anxiety scale. Only patients with definite depression and/or anxiety
will be considering participating this trial.
3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
4. Patients should be expected to live no shorter than 1.5 months
The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The
second outcomes include anxious and depression scores, objective response rate, progress
free survival, overall Survival and chemotherapy induced nausea and vomiting.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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