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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832520
Recruitment Status : Terminated (Low accrual rate.)
First Posted : January 30, 2009
Results First Posted : December 18, 2012
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Remeron (mirtazapine) Phase 2

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). 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
Study Start Date : November 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Mirtazapine

Arm Intervention/treatment
Experimental: Remeron (Mirtazapine)
Mirtazapine 15 mg orally at bed time for 8 weeks
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

Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. To Determine if the Quality of Life Improves After Starting Mirtazapine [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832520

United States, New Mexico
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Principal Investigator: Claire Verschraegen, M.D. University of New Mexico Cancer Center

Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00832520     History of Changes
Other Study ID Numbers: INST 0816
First Posted: January 30, 2009    Key Record Dates
Results First Posted: December 18, 2012
Last Update Posted: April 10, 2018
Last Verified: March 2018

Keywords provided by New Mexico Cancer Care Alliance:
Advanced cancer
weight loss
body weight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation