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

This study has been terminated.
(Low accrual rate.)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832520
First received: January 29, 2009
Last updated: October 29, 2013
Last verified: November 2012

January 29, 2009
October 29, 2013
November 2008
July 2010   (final data collection date for primary outcome measure)
Change in Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
To determine the efficacy of Mirtazapine to reduce weight loss in patients with advanced cancer [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832520 on ClinicalTrials.gov Archive Site
To Determine if the Quality of Life Improves After Starting Mirtazapine [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To determine if the quality of life improves after starting mirtazapine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Advanced Cancer
Drug: Remeron (mirtazapine)

Mirtazapine 15 mg orally at bed time. Patients with a creatinine clearance < 50% or a bilirubin or transaminases > twice the upper limit of normal will take a 7.5 mg dose.

  • Drug Administration: Drug will be administered orally, every day for a period of 8 weeks
  • Dose modifications: None
Other Name: mirtazapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
June 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832520
INST 0816
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Claire Verschraegen, M.D. University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP