Effects of Mirtazapine on Appetite in Advanced Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488072
First received: June 18, 2007
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).

Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)

Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)

Other Objectives:

To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days).

To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).


Condition Intervention
Advanced Cancer
Anorexia
Weight Loss
Insomnia
Drug: Mirtazapine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Comparison of ESAS scores in Appetite [ Time Frame: Baseline, and on days (+/-3) 15 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insomnia (as measured by Pittsburgh Sleep Quality Index) [ Time Frame: On day 15 ( +/- 3 days), and day 29 ( +/- 3 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: January 2007
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirtazapine
Mirtazapine 15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.
Drug: Mirtazapine
15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.
Placebo Comparator: Placebo
One placebo tablet by mouth daily.
Drug: Placebo
One placebo tablet by mouth daily.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS.
  2. Patients > 18 years of age
  3. Karnofsky Performance score of > 40 at time of inclusion into study
  4. Ability to provide informed consent and comply with study procedures
  5. Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days).
  6. Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment.
  7. For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist
  8. Drowsiness of </= 4/10 on ESAS at baseline due to known potential sedating effects of Mirtazapine
  9. Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study (with the permission of their Attending MD) if they have been on stable dose for at least 2 weeks.
  10. Patients who are on stable doses of antidepressants for at least 2 months.

Exclusion Criteria:

  1. Patients who have known dementia or delirium at time of enrollment as determined by a physician.
  2. Known hypersensitivity to any ingredient of Mirtazapine
  3. Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting
  4. Ongoing use of tube feeding or parenteral nutrition
  5. Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment.
  6. Pregnancy or lactation or unwillingness to use contraceptives
  7. A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation.
  8. Patients on chronic use of benzodiazepines are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488072

Locations
United States, Texas
UT MD . Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Shalini Dalal, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488072     History of Changes
Other Study ID Numbers: 2005-0916
Study First Received: June 18, 2007
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Anorexia
Weight Loss
Insomnia
Appetite
Mirtazapine
Placebo

Additional relevant MeSH terms:
Anorexia
Weight Loss
Neoplasms
Sleep Initiation and Maintenance Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Body Weight Changes
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Mirtazapine
Mianserin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on April 22, 2014