Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 not been approved by the Food and Drug Administration for use to treat weight loss.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Treatments: Mianserin; Mirtazapine

Criteria

Inclusion Criteria:

1. All patients, 18 years of age or older, with advanced cancer are eligible.

2. Patients must have lost 10% in the last 6 months

3. Patients must have a life expectancy of at least 12 weeks.

4. Patients must have a Zubrod performance status of 0-3.

5. Patients must sign an informed consent.

Exclusion Criteria:

1. Patients with symptomatic brain metastases are excluded from this study.

2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

3. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

4. 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

5. Patients who lost weight on a voluntary diet.

6. Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.

7. Patients who had surgery in the last 6 months