Status:
TERMINATED
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has...
Detailed Description
Weight loss in cancer patients can be the result of inadequate intake or absorption of nutrients and/or tumor-induced weight loss due to metabolic changes the tumor is creating in the body (1). Inadeq...
Eligibility Criteria
Inclusion
- All patients, 18 years of age or older, with advanced cancer are eligible.
- Patients must have lost 10% in the last 6 months
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-3.
- Patients must sign an informed consent.
Exclusion
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- Patients with head and neck cancers and GI cancers who have functional problems that limits food intake or absorption of nutrients such as partial or complete bowel obstructions, and patients with skin cancers (except melanoma) are not eligible
- Patients who lost weight on a voluntary diet.
- Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.
- Patients who had surgery in the last 6 months
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00832520
Start Date
November 1 2008
End Date
June 1 2011
Last Update
April 10 2018
Active Locations (2)
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1
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
2
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87106