Clinical trial · Interventional
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
NCT00832520CI-TRIAL-00032450terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual rate.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remeron (mirtazapine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Remeron (Mirtazapine)
- description
- Mirtazapine 15 mg orally at bed time for 8 weeks
- interventionNames
- Drug: Remeron (mirtazapine)
Primary outcomes (1)
- measure
- Change in Weight
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- To Determine if the Quality of Life Improves After Starting Mirtazapine
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4. PMID 36999619