Anorexia Nervosa with Significantly Low Body WeightPhase 2NCT05170919
Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
A Phase 2 study testing Mirtazapine and Olanzapine in people with Anorexia Nervosa with Significantly Low Body Weight, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa with Significantly Low Body Weight
- What is being tested?
- Mirtazapine and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Read the 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.
- Being tested
- Mirtazapine, Olanzapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.
OlanzapineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Not described Receives: Drug: Olanzapine |
| Mirtazapine | Experimental | Not described Receives: Drug: Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start20 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa with Significantly Low Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170919
- Sponsor's protocol ID
- E-21-862
- Status last verified
- Sep 2024
- First submitted
- 19 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
- ClinicalTrials.gov ID
- NCT05170919
- Acronym / sponsor ID
- E-21-862
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine |
| Mirtazapine | Experimental | Drug: Mirtazapine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • 18 years of age or older
- o Scheduled to start, have discontinued or completed, or currently receiving
- 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).
Key exclusion criteria (5 listed)
- • Abnormal liver function defined as > twice upper limit of normal
- o EKG performed within 1 year of enrollment will be accepted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtazapinePatients will be prescribed a dosage of 15 mg per day. Dose will not be escalated. | Drug | Mirtazapine |
| Olanzapinethe 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. | Drug | Olanzapine |
Primary outcome
Weight
Time frame: 6 months
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.
1 secondary outcome
Quality of Life of patient
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa with Significantly Low Body Weight
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirtazapine and Olanzapine in people with Anorexia Nervosa with Significantly Low Body Weight, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.