INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
18 Years
N/A
Both
Advanced Cancer
Trial Information
INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
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). Inadequate intake resulting in a starvation state can simply be the result of
eating less due to depression, nausea/vomiting, feelings of fullness, and taste changes (2).
Though not intentional the weight loss caused by these symptoms can be explained and
reversed by increasing intake of nutrients. Unintentional weight loss induced by the tumor
can be caused by multiple physiological factors that increase the catabolism of muscle and
fat and increased nutrient intake alone may not reverse the weight loss. Unintentional
weight loss can predict a poor prognosis in cancer patients which is most likely due to
decreased doses of treatment (3-5).
Usual care for weight loss in cancer patients varies among practitioners and can include
nutrition counseling by a registered dietitian or by the practitioner themselves. Treatment
can vary from counseling patients to increase intake of nutrient dense foods to prescribing
medications in order to improve appetite or mood, to decrease feelings of fullness, or to
control nausea/vomiting, etc. (6). However, these interventions do not always work. For
varied reasons not all patients are able to improve their oral intake of food items and in
patients with tumor induced weight loss increased oral intake does not improve the metabolic
changes.
Anti-depressant medications have weight related side effects (7-9). Mirtazapine has been
shown to have side effects of increased appetite and increased weight in cancer subjects
studied for use with depression and nausea. (10-13). These results appeared to range from
changes in appetite to changes seen in metabolic processes such as changes in the cytokine
system to reduce inflammation seen in cachectic patients. Therefore, using mirtazapine in
cancer patients even without depression may help to stop unwanted weight loss and increase
survival by allowing patient to complete prescribed treatment.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Change in Weight
Outcome Time Frame:
8 weeks
Safety Issue:
Yes
Principal Investigator
Claire Verschraegen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of New Mexico Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
INST 0816
NCT ID:
NCT00832520
Start Date:
November 2008
Completion Date:
June 2011
Related Keywords:
- Advanced Cancer
- Advanced cancer
- weight loss
- Remeron
- body weight
- Body Weight
- Neoplasms
Name | Location |
|---|---|
| University of New Mexico Cancer Center @ Lovelace Medical Center | Albuquerque, New Mexico 87102 |
| Universtiy of New Mexico - Cancer Center | Albuquerque, New Mexico 87106 |
