Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Intervention
Name: Mirtazapine plus gemcitabine Type: Drug
Name: Gemcitabine, placebo Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

1. Patients of pancreatic cancer 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

Exclusion Criteria:

1. Patients receiving other anti-cancer drugs;

2. 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;

3. Patient with inadequate Blood system,liver function and renal function.

4. Brain metastasis is of symptoms

5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;

6. Chronic enteritis or intestinal obstruction

7. Bone marrow failure

8. Mental disease difficult to control

9. Participated other clinic trial within 3 months

10. Pregnant or lactation patients

11. The researcher evaluate the patient is not suitable for this trial.
Location
TianjinCIH
Tianjin, Tianjin, China
Status: Recruiting
Contact: Yi Ba, MD.PHD - +8613920893142 - zhoubaling123@163.com
Start Date
June 2012
Completion Date
December 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page