Cachexia; CancerPhase 2NCT03283488
Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.
A Phase 2 study testing Mirtazapine and Megestrol in people with Cachexia; Cancer and Anorexia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Despite its clinical importance, it remains a widely underestimated and untreated condition. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cachexia; Cancer, Anorexia
- What is being tested?
- Mirtazapine and Megestrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Mar 2019to 2 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 50 years.
- Patients with confirmed diagnosis of cancer by histopathological examination, including those not yet submitted to any therapy because they are in the therapeutic definition phase and those whose therapies have already been suspended because they are ineffective.
- Patients with cancer progression, with either local or distant metastases, documented by radiological or histopathological methods.
- Patients complaining of anorexia graded by the patient as ≥ 5 by the Edmonton Sympton Assessement Scale.
- Patients with weight loss ≥ 2% in the last 2 months or weight loss ≥ 5% in the last 6 months, referred by the patient or documented in electronic medical records, compared to the stable weight before diagnosis.
- Patients with a life expectancy of ≥ 2 months by the Palliative Prognostic Score.
- Patients with performance status greater than or equal to 60% using the Karnofsky Performance Status scale.
Who cannot join
- Patients diagnosed with depression or using antidepressant therapy with a score ≥ 12 in the depression items of the Hospital Anxiety and Depression Scale.
- Patients with unstable doses of corticosteroids.
- Patients with moderate renal and/or hepatic dysfunction (total bilirubin ≥ 1.5x the upper limit of normal, AST and ALT ≥ 5x upper limit of normal or creatinine ≥1.5x upper limit of normal).
- Patients with Central Nervous System metastases.
- Patients with inability to take oral medications.
- Patients with mechanical obstruction of the gastrointestinal tract.
Show all 12Show fewer
- Patients with clinically bulky ascites and generalized edema.
- Patients with reports of allergy to the medications studied.
- Patients with hypothyroidism with TSH levels greater than or equal to 5 μU/mL and free T4 less than 0.7 ng/dL.
- Patients with uncorrected hydroelectrolytic disturbances, with altered serum sodium, potassium and/ or ionic calcium.
- Patients with persistent and uncontrolled nausea and/or vomiting associated with gastrointestinal tract neoplasia and/or chemotherapeutic or radiotherapeutic treatment.
- Patients with pacemakers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: Randomized, Double-blind Clinical Trial of the Use of Mirtazapine Versus Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Despite its clinical importance, it remains a widely underestimated and untreated condition. Considering the scarcity of pharmacological measures, it is necessary to invest in studies that may contribute to the rational and effective treatment of this clinical condition. Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few adverse effects and with well-known orexigenic action in clinical practice.The objective of this study is to evaluate the effect of mirtazapine as a pharmacological measure in the management of cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body composition, quality of life, and functional capacity of patients.
Read the detailed description
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Unintentional weight loss can predict a poor prognosis in cancer patients which is most likely due to decreased doses of treatment. Despite its clinical importance, it remains a widely underestimated and untreated condition. Considering the scarcity of pharmacological measures, it is necessary to invest in studies that may contribute to the rational and effective treatment of this clinical condition. Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few adverse effects and with well-known orexigenic action in clinical practice. It has been shown to have side effects of increased appetite and weight gain in cancer subjects with depression and nausea, as well as in non-depressed cancer patients, but there are not, as yet, randomized controlled trials showing its effect on cancer-associated anorexia-cachexia. The objective of this study is to evaluate the effect of mirtazapine as a pharmacological measure in the management of cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and will be evaluated longitudinally for a period of 8 weeks. After the initial evaluation and randomization, patients will be reassessed after 4 and 8 weeks at an outpatient clinic where they will be evaluated for the following variables: (1) General and demographic characteristics; (2) Usual food intake; (3) Anthropometric evaluation; (4) Presence and degree of symptoms using the Edmonton Symptom Assessment System; (4) Status performance using the Karnofsky performance status; (5) Quality of life using the QLQ-C30 Questionnaire; (6) Depression using the Hospital Anxiety and Depression Scale; (7) Prognosis using the Palliative Prognostic Score; (8) Evaluation of functional capacity using hand grip strength and gait speed; (9) Body composition using electrical bioimpedance and dual energy x-ray absorptiometry; (10) Physical Activity Behaviour using a tri-axial accelerometer. Patients will also be contacted via telephone calls at weeks 1, 2, 3, 5 and 6 for information regarding adverse events and drug compliance. The questioning about the occurrence of adverse events will also be performed at the outpatient clinic. Self-report of ingestion of tablets and counting of tablets on return of packages at the end of the study will be used to determine patient compliance. It is expect that use of mirtazapine can bring benefits increasing appetite and the body weight in cancer patientes in palliative care compared to the use of megestrol.
- Conditions
- Cachexia; Cancer, Anorexia
- Being tested
- Mirtazapine, Megestrol
- Keywords
- anorexia, cachexia, mirtazapine, megestrol, palliative care
- Medical subject headings
- Cachexia, Neoplasms, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called Remeron
Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
MegestrolDrug
Also called megestrol acetate
Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. Receives: Drug: Mirtazapine |
| Megestrol | Active comparator | Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. Receives: Drug: Megestrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appetite
Assessed by Edmonton Symptom Assessment Scale. This evaluation will be collected at baseline and after 8 weeks of follow-up. Changes in appetite will be divided into 3 categories according to the following definitions: appetite improvement will be a decrease ≥ 2 points in Edmonton Symptom Assessment Scale, maintenance of appetite as an improvement or worsening of 1 point and worsening of appetite as deterioration ≥ 2 points.
Measured: 8 weeks
Change in body weight
Assessed by body weight. This evaluation will be collected at baseline and after 8 weeks of follow-up. The weight changes will be divided into 3 categories according to the following definitions: weight improvement will be a gain ≥ 1 kg, weight maintenance will be a loss < 500g or a gain < 1kg and weight loss will be a loss ≥ 500g.
Measured: 8 weeks
Secondary outcomes (6)
Change in body lean and fat mass
Assessed by body bioelectrical impedance and dual energy x-ray absorptiometry. They will be performed at baseline and after 8 weeks of follow-up. The body bioelectrical impedance will be performed using the ImpediMed DF50 mono-frequency system (ImpediMed Limited, Australia). The dual energy x-ray absorptiometry will be performed on the measuring table using the equipment-specific software.
Measured: 8 weeks
Change in Quality of life
The European Organization for Research and Treatment of Cancer (EORTC) instrument QLQ-C30 Questionnaire will be used to assess quality of life at baseline and after 8 weeks of follow-up.
Measured: 8 weeks
Assessment of muscle strength
Assessed by hand grip strenght measured by the use of a manual hydraulic dynamometer (Saehan, model SH 5.001, Koreia). It will be performed at baseline and after 8 weeks of follow-up.
Measured: 8 weeks
Assessment of gait speed
The gait speed will be measured at 4 meters on usual speed. It will be performed at baseline and after 8 weeks of follow-up. The results will be expressed in m/s.
Measured: 8 weeks
Physical Activity behaviour
Assessed by a tri-axial accelerometer to measure profile of spontaneous physical activity. It will be performed at first week and the last week of follow-up.
Measured: 8 weeks
Incidence of treatment-related Adverse Events
Assessed by contact via telephone calls at weeks 1, 2, 3, 5 and 6 for information regarding treatment-related adverse events. The questioning about the occurrence of treatment-related adverse events will also be performed at the outpatient clinic at baseline and weeks 4 and 8 during the follow-up.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start26 Mar 2019
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nereida Kilza da Costa Lima, University of Sao Paulo
- Investigators
- Nereida KC Lima, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283488
- Sponsor's protocol ID
- Mirtazapine_Cachexia
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2017
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be made available after the end of the study protocol.
Publications
Riechelmann RP, Burman D, Tannock IF, Rodin G, Zimmermann C. Phase II trial of mirtazapine for cancer-related cachexia and anorexia. Am J Hosp Palliat Care. 2010 Mar;27(2):106-10. doi: 10.1177/1049909109345685. Epub 2009 Sep 23.
PubMed 19776373Theobald DE, Kirsh KL, Holtsclaw E, Donaghy K, Passik SD. An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. J Pain Symptom Manage. 2002 May;23(5):442-7. doi: 10.1016/s0885-3924(02)00381-0.
PubMed 12007762Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.
PubMed 12937858Wen HS, Li X, Cao YZ, Zhang CC, Yang F, Shi YM, Peng LM. Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide. Chemotherapy. 2012;58(6):461-7. doi: 10.1159/000346446. Epub 2013 Feb 7.
PubMed 23406994
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Clinical Trial of the Use of Mirtazapine Versus Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.
- ClinicalTrials.gov ID
- NCT03283488
- Acronym / sponsor ID
- Mirtazapine_Cachexia
- Conditions
- Cachexia; Cancer, Anorexia
- Keywords
- anorexia, cachexia, mirtazapine, megestrol, palliative care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 14 Sep 2017 (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.
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Despite its clinical importance, it remains a widely underestimated and untreated condition. Considering the scarcity of pharmacological measures, it is necessary to invest in studies that may contribute to the rational and effective treatment of this clinical condition. Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few adverse effects and with well-known orexigenic action in clinical practice.The objective of this study is to evaluate the effect of mirtazapine as a pharmacological measure in the management of cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body composition, quality of life, and functional capacity of patients.
Detailed description
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Unintentional weight loss can predict a poor prognosis in cancer patients which is most likely due to decreased doses of treatment. Despite its clinical importance, it remains a widely underestimated and untreated condition. Considering the scarcity of pharmacological measures, it is necessary to invest in studies that may contribute to the rational and effective treatment of this clinical condition. Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few adverse effects and with well-known orexigenic action in clinical practice. It has been shown to have side effects of increased appetite and weight gain in cancer subjects with depression and nausea, as well as in non-depressed cancer patients, but there are not, as yet, randomized controlled trials showing its effect on cancer-associated anorexia-cachexia. The objective of this study is to evaluate the effect of mirtazapine as a pharmacological measure in the management of cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and will be evaluated longitudinally for a period of 8 weeks. After the initial evaluation and randomization, patients will be reassessed after 4 and 8 weeks at an outpatient clinic where they will be evaluated for the following variables: (1) General and demographic characteristics; (2) Usual food intake; (3) Anthropometric evaluation; (4) Presence and degree of symptoms using the Edmonton Symptom Assessment System; (4) Status performance using the Karnofsky performance status; (5) Quality of life using the QLQ-C30 Questionnaire; (6) Depression using the Hospital Anxiety and Depression Scale; (7) Prognosis using the Palliative Prognostic Score; (8) Evaluation of functional capacity using hand grip strength and gait speed; (9) Body composition using electrical bioimpedance and dual energy x-ray absorptiometry; (10) Physical Activity Behaviour using a tri-axial accelerometer. Patients will also be contacted via telephone calls at weeks 1, 2, 3, 5 and 6 for information regarding adverse events and drug compliance. The questioning about the occurrence of adverse events will also be performed at the outpatient clinic. Self-report of ingestion of tablets and counting of tablets on return of packages at the end of the study will be used to determine patient compliance. It is expect that use of mirtazapine can bring benefits increasing appetite and the body weight in cancer patientes in palliative care compared to the use of megestrol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: MirtazapineTablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. |
| Megestrol | Active comparator | Drug: MegestrolTablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥ 50 years.
- Patients with confirmed diagnosis of cancer by histopathological examination, including those not yet submitted to any therapy because they are in the therapeutic definition phase and those whose therapies have already been suspended because they are ineffective.
- Patients with cancer progression, with either local or distant metastases, documented by radiological or histopathological methods.
- Patients complaining of anorexia graded by the patient as ≥ 5 by the Edmonton Sympton Assessement Scale.
- Patients with weight loss ≥ 2% in the last 2 months or weight loss ≥ 5% in the last 6 months, referred by the patient or documented in electronic medical records, compared to the stable weight before diagnosis.
Key exclusion criteria (12 listed)
- Patients diagnosed with depression or using antidepressant therapy with a score ≥ 12 in the depression items of the Hospital Anxiety and Depression Scale.
- Patients with unstable doses of corticosteroids.
- Patients with moderate renal and/or hepatic dysfunction (total bilirubin ≥ 1.5x the upper limit of normal, AST and ALT ≥ 5x upper limit of normal or creatinine ≥1.5x upper limit of normal).
- Patients with Central Nervous System metastases.
- Patients with inability to take oral medications.
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 |
|---|---|---|
| MirtazapineAlso: RemeronTablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. | Drug | Mirtazapine |
| MegestrolAlso: megestrol acetateTablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study. | Drug | Megestrol |
Primary outcome
Change in appetite
Time frame: 8 weeks
Assessed by Edmonton Symptom Assessment Scale. This evaluation will be collected at baseline and after 8 weeks of follow-up. Changes in appetite will be divided into 3 categories according to the following definitions: appetite improvement will be a decrease ≥ 2 points in Edmonton Symptom Assessment Scale, maintenance of appetite as an improvement or worsening of 1 point and worsening of appetite as deterioration ≥ 2 points.
Change in body weight
Time frame: 8 weeks
Assessed by body weight. This evaluation will be collected at baseline and after 8 weeks of follow-up. The weight changes will be divided into 3 categories according to the following definitions: weight improvement will be a gain ≥ 1 kg, weight maintenance will be a loss < 500g or a gain < 1kg and weight loss will be a loss ≥ 500g.
6 secondary outcomes
Change in body lean and fat mass
Time frame: 8 weeks
Change in Quality of life
Time frame: 8 weeks
Assessment of muscle strength
Time frame: 8 weeks
Assessment of gait speed
Time frame: 8 weeks
Physical Activity behaviour
Time frame: 8 weeks
Incidence of treatment-related Adverse Events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 19776373Riechelmann RP, Burman D, Tannock IF, Rodin G, Zimmermann C. Phase II trial of mirtazapine for cancer-related cachexia and anorexia. Am J Hosp Palliat Care. 2010 Mar;27(2):106-10. doi: 10.1177/1049909109345685. Epub 2009 Sep 23.
- Background: PubMed 12007762Theobald DE, Kirsh KL, Holtsclaw E, Donaghy K, Passik SD. An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. J Pain Symptom Manage. 2002 May;23(5):442-7. doi: 10.1016/s0885-3924(02)00381-0.
- Background: PubMed 12937858Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.
- Background: PubMed 23406994Wen HS, Li X, Cao YZ, Zhang CC, Yang F, Shi YM, Peng LM. Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide. Chemotherapy. 2012;58(6):461-7. doi: 10.1159/000346446. Epub 2013 Feb 7.
- webpage of the Ribeirão Preto Medical SchoolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD to be made available after the end of the study protocol.
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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. This study is not recruiting at the moment.
Nereida KC Lima, MD, PhD principal investigator
University of Sao Paulo
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 Megestrol in people with Cachexia; Cancer and Anorexia, run by University of Sao Paulo at 1 site in Brazil.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jul 2023. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in appetite (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283488, which also lists 4 linked publications.
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 7 Jul 2023.