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
  Purpose

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 Intervention Phase
Advanced Cancer
Drug: Remeron (mirtazapine)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Change in Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To Determine if the Quality of Life Improves After Starting Mirtazapine [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832520

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

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832520     History of Changes
Other Study ID Numbers: INST 0816
Study First Received: January 29, 2009
Results First Received: July 20, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Body Weight
Neoplasms
Signs and Symptoms
Mirtazapine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 18, 2014