Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Tianjin Medical University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine, placebo; Drug: Mirtazapine plus gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01598584

TJ20111123

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

placebo plus gemcitabine

Placebo Comparator group

Description:

we design placebo plus gemcitabine as control arm

Treatment:

Drug: Gemcitabine, placebo

Mirtazapine plus gemcitabine

Experimental group

Description:

We design Mirtazapine plus gemcitabine as experimental arm

Treatment:

Drug: Mirtazapine plus gemcitabine