Clinical trialPhase 2 / Phase 3Withdrawn
Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
- Outcome
- Stopped earlyGemcitabine is not the first choice for most pancreatic cancer patients nowdays (Other)
- Phase
- Phase 2 / Phase 3
- Status
- Withdrawn
- Study type
- Interventional
- Start
- June 2012
- Expected end
- December 2015
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- quality of life
- Sponsor
- Other
- Results posted
- No
- Last update
- 28 September 2015
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.