Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Patients shall have normal organic function such as liver function, Cardiac function and renal function. 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. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled. 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.

Official Title
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A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Mirtazapine plus gemcitabine
* Drug: Gemcitabine, placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function. 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. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled. Patients should be expected to live no shorter than 1.5 months Exclusion Criteria: Patients receiving other anti-cancer drugs; Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation; Patient with inadequate Blood system,liver function and renal function. Brain metastasis is of symptoms Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease; Chronic enteritis or intestinal obstruction Bone marrow failure Mental disease difficult to control Participated other clinic trial within 3 months Pregnant or lactation patients The researcher evaluate the patient is not suitable for this trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo plus gemcitabine<br>we design placebo plus gemcitabine as control arm | Drug: Gemcitabine, placebo<br>* Gemcitabine 1.0g/m2,d1,d8,q3w placebo<br>* Other names: randomised control trial;|
| Experimental: Mirtazapine plus gemcitabine<br>We design Mirtazapine plus gemcitabine as experimental arm | Drug: Mirtazapine plus gemcitabine<br>* 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<br>* Other names: pancreatic cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | primary outcome is the quality of life evaluated by SF-36 scale | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety and depression scores | The second outcomes include anxious and depression scores | up to 3 years | 
| objective response rate |  | up to 3 years | 
| progress free survival, |  | up to 3 years | 
| overall Survival |  | up to 3 years | 
| chemotherapy induced nausea and vomiting |  | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer