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Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer

Primary Purpose

Anorexia Nervosa With Significantly Low Body Weight

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mirtazapine
Olanzapine
Sponsored by
Englewood Hospital and Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa With Significantly Low Body Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 18 years of age or older

    • Able to provide informed consent
    • Pathologically and/or clinically confirmed diagnosis of advanced cancer

    • At any point of treatment with standard chemotherapy*

      o Scheduled to start, have discontinued or completed, or currently receiving

    • Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation

      o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).

    • Life expectancy of at least 4 months

    • Able to communicate well and comply with study requirements, including by phone and written logs

      • Patients on Dexamethasone will be allowed

Exclusion Criteria:

  • • Abnormal liver function defined as > twice upper limit of normal

    • Elevated QTc

      o EKG performed within 1 year of enrollment will be accepted

    • Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of their primary source of daily calorie intake
    • Taking Marinol within 2 week of enrollment onto study

Sites / Locations

  • Englewood Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Olanzapine

Mirtazapine

Arm Description

Outcomes

Primary Outcome Measures

Weight
Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact.

Secondary Outcome Measures

Quality of Life of patient
Patients will complete a quality of life (QOL) questionnaire provided at each time point. The higher the score, the worse the outcome. Patients will rate their improvement on a scale from 0 to 4.

Full Information

First Posted
November 19, 2021
Last Updated
July 25, 2022
Sponsor
Englewood Hospital and Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05170919
Brief Title
Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer
Official Title
An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Detailed Description
Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa With Significantly Low Body Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Title
Mirtazapine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
the participant will be prescribed a dosage of 2.5mg per day if > 65 yrs. and 5 mg/per day if <65 yrs. per day. Per physician discretion, participants are allowed a dose escalation of a maximum of 10mg.
Primary Outcome Measure Information:
Title
Weight
Description
Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life of patient
Description
Patients will complete a quality of life (QOL) questionnaire provided at each time point. The higher the score, the worse the outcome. Patients will rate their improvement on a scale from 0 to 4.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 18 years of age or older Able to provide informed consent Pathologically and/or clinically confirmed diagnosis of advanced cancer At any point of treatment with standard chemotherapy* o Scheduled to start, have discontinued or completed, or currently receiving Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period). Life expectancy of at least 4 months Able to communicate well and comply with study requirements, including by phone and written logs Patients on Dexamethasone will be allowed Exclusion Criteria: • Abnormal liver function defined as > twice upper limit of normal Elevated QTc o EKG performed within 1 year of enrollment will be accepted Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of their primary source of daily calorie intake Taking Marinol within 2 week of enrollment onto study
Facility Information:
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer

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