Pancreatic Cancer
Conditions
Keywords
Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer
Brief 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.
Interventions
DRUGMirtazapine 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
DRUGGemcitabine, placebo
Gemcitabine 1.0g/m2,d1,d8,q3w placebo
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | up to 3 years | primary outcome is the quality of life evaluated by SF-36 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anxiety and depression scores | up to 3 years | The second outcomes include anxious and depression scores |
| 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 | — |
Countries
China
Outcome results
None listed