NCT00832520

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 18, 2012

Completed
Last Updated

April 10, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

January 29, 2009

Results QC Date

July 20, 2012

Last Update Submit

March 14, 2018

Conditions

Advanced Cancer

Keywords

Advanced cancerweight lossRemeronbody weight

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    8 weeks

Secondary Outcomes (1)

  • To Determine if the Quality of Life Improves After Starting Mirtazapine

    8 weeks

Study Arms (1)

Remeron (Mirtazapine)

EXPERIMENTAL

Mirtazapine 15 mg orally at bed time for 8 weeks

Drug: Remeron (mirtazapine)

Interventions

Remeron (mirtazapine)DRUG

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

Also known as: mirtazapine
Remeron (Mirtazapine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients, 18 years of age or older, with advanced cancer are eligible.
  • Patients must have lost 10% in the last 6 months
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must have a Zubrod performance status of 0-3.
  • Patients must sign an informed consent.

You may not qualify if:

  • Patients with symptomatic brain metastases are excluded from this study.
  • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  • Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
  • 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
  • Patients who lost weight on a voluntary diet.
  • Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.
  • Patients who had surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico Cancer Center @ Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Universtiy of New Mexico - Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

  • Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

    PMID: 36999619DERIVED

MeSH Terms

Conditions

Weight LossBody Weight

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Early termination leading to no subjects analyzed.There will be no publication, as this study was terminated after the original PI left employment with the institution.

Results Point of Contact

Title
Valerie Parks, RN
Organization
UNM Comprehensive Cancer Center
vparks@salud.unm.edu
505-925-0390

Study Officials

  • Claire Verschraegen, M.D.

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

June 1, 2011

Last Updated

April 10, 2018

Results First Posted

December 18, 2012

Record last verified: 2018-03

Locations

US(2)