Advanced CancerPhase 2/3MCACS100NCT03254173
Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia
A Phase 2/3 study testing Mirtazapine 30 mg oral tablets in people with Advanced Cancer and Cancer Associated Anorexia - Cachexia, run by Catherine Naseef Hunter at 1 site in Egypt.
Trial summary
A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome. Two arms will be compared . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Cancer Associated Anorexia - Cachexia
- What is being tested?
- Mirtazapine 30 mg oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2018to 17 Oct 2019
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed advanced cancer.
- Patients with appetite score equal or more than 4 on a 0 to 10 scale (10 _ worst appetite).
- Patients with weight loss more than 5 % of body weight over 6 months . Or : Patients with any degree of weight loss more than 2 % associated with BMI ( body mass index ) of less than 20.
- Patients able to take pills orally and not dependent on tube feeding (no oral mucosal inflammation interfering with oral intake or dysphagia as determined by clinical examination).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).
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- Ability to understand and willingness to sign written informed consent.
- Patients could be receiving concurrent chemotherapy or radiation therapy.
- Patients with an expected life span of at least 3 months.
Who cannot join
- Patients with weight gain for known cause , e.g. , ascites.
- Premenopausal women with childbearing potential with a positive pregnancy test.
- Patients unable to maintain oral intake .
- Patients with dementia or delirium.
- Patients with uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression will be excluded until their symptoms had stabilized for at least 2 weeks.
- Because improvement in anorexia and/or weight in depressed individuals could be due to an antidepressant effect of mirtazapine, rather than to a direct effect on anorexia, patients with moderate to severe depressive symptoms will be also excluded. the screening instrument will be a single-item interview assessing depressed mood of the Schedule for Affective Disorders and Schizophrenia (SADS) instrument which is validated and highly accurate in screening for depression when compared to the gold standard of semistructured diagnostic interviews, and is rated on a 6-point Likert scale, where 0 = no depression and 6 = extreme feelings of depression. Patients with a score of 4 or more will be excluded from the study as they are considered to be at high risk for depression.
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- No treatment with antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days prior to or during protocol therapy.
- Patients with untreated vitamin B12 deficiency or endocrine abnormalities that could affect appetite, such as thyroid dysfunction and hypoadrenalism.
- Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide, will be excluded unless they are put on a stable dose for more than 2 weeks and continue to experience poor appetite.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia : a Randomized Controlled Clinical Trial
A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.
Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer receiving mirtazapine 15 mg once daily for 8 weeks \& Arm B will involve another 50 patients with confirmed advanced cancer receiving placebo for 8 weeks.
Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation primarily and to assess other outcomes secondarily which will be discussed later in details.
Read the detailed description
- A Written consent is to be obtained from all patients before being enrolled in the study.
- Baseline Complete Blood Count , Liver function tests and kidney function tests will be obtained to assess safety to start the drug and to assess its dose adjustment.
- Two arms will be compared : mirtazapine oral 15mg daily versus placebo. This will be conducted on a double-blinded basis.
- Oral mirtazapine ( REMERON , RD , 30 mg tablets , Organon ) will be the original FDA approved drugs that will be used in the study.
- Treatment allocation will be concealed from patients, investigators, and study coordinators enrolling the participants.
- All patients will be counseled and given dietary advice by a dietician at baseline.
- Patients will be permitted to continue treatment at the same dose as scheduled as long as weight was stabilized (no loss greater than 10 % of body weight at baseline).
- Duration of therapy : Patients will remain on protocol for a duration of 8 weeks as long as they did not develop serious concurrent illness preventing further treatment, unacceptable adverse events (grade 3 or higher), the patient decides to withdraw from study, or the investigator judges that it is in the patient's best interest to discontinue treatment due to general or specific health conditions.
- Demographic data will include performance status, tumor type, sex, age, and percentage weight loss.
- The ESAS scale (Edmonton Symptom Assessment Scale ) will be used to assess the following 10 symptoms experienced by patients with cancer during the previous 24 hours:
- pain.
- Fatigue.
- Nausea.
- Depression.
- Anxiety.
- Drowsiness.
- Dyspnea.
- Anorexia.
- Sleep disturbance.
- And feelings of well-being.
The severity of each symptom is rated on a numerical scale of 0 to 10 (0_no symptom, 10_worst possible severity). The ESAS is both valid and reliable in the assessment of the intensity of symptoms in patients with cancer.
- The FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale will be used to assess quality of life among the studied patients , in a form of questionnaire including :
- Physical well-being.
- Social well-being.
- Emotional well-being.
- Functional well-being.
- Additional concerns. The patient rates the answer on a scale of 0 to 4. The FACIT - Pal scale is internally consistent , reliable and valid as a measure of health-related quality of life for persons with advanced cancer. We will contact their website to get the licence to use the questionnaire and to get its translated version.
- Anthropometric measures to assess efficacy of mirtazapine in weight gain :
- Assessment of weight of the patient .
- Assessment of muscle strength ( via hand grip dynamometry , using the device named Lite 200 lb , Fabrication Enterprises Incorporated Company).
- Assessment of lean ( via bioimpedance analysis , using the device named BF100 , Beurer Company ).
- Biological methods to assess efficacy of mirtazapine in modulating inflammatory cytokine media : quantitative c-reactive protein (CRP) and comparative analysis by enzyme-linked immunoassay (ELISA) will be performed on IL-6 ( Interleukin - 6 ) , and YKL-40 serum levels according to availability. They will be obtained at baseline (day 1 of treatment, immediately before first dose) and at week 8.
- Evaluation of safety and tolerability Patients who will receive at least one dose of study medication will be done.
- A traditional definition of dose-limiting toxicity (DLT) within the first cycle Will be used (any grade 3 non-hematologic or grade 4 hematologic toxicity within 4 weeks and assessed as being at least possibly related to study drug).
- A toxicity questionnaire will be done at baseline and then at 14-day intervals until day 28.
To fully assess the toxicity profile of the drug, the safety evaluation period in the trial will be extended 30 days from the date of the last dose of study drug.
- Being tested
- Mirtazapine 30 mg oral tablets, Placebo oral tablets
- Keywords
- Mirtazapine, Anorexia - Cachexia, Advanced Cancer, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 30 mg oral tabletsDrug
Also called Remeron 30 mg oral tablets
Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets) , half tablet before sleep for 8 weeks
Placebo oral tabletsDrug
Placebo oral tablets , half tablet daily before sleep for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets ) , as half tablet daily , i.e , 15mg daily , before sleep for a duration of 8 weeks Receives: Drug: Mirtazapine 30 mg oral tablets |
| Arm B | Placebo comparator | Placebo oral tablets , as half tablet daily before sleep for a duration of 8 weeks Receives: Drug: Placebo oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase of 1.5 degree on a numerical scale of 0 -10 as a target .
Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase 1.5 degree on a scale of 0-10 as a target , where 0 represents minimum appetite and 10 represents maximum appetite.
Measured: It will be assessed at week 4 of receiving the intervention. The 4-week duration of treatment is of sufficient length to obtain benefit from an effective intervention for appetite.
Secondary outcomes (5)
Efficacy of mirtazapine in weight gain. ''Improved'' weight will be defined as a gain of ≥ 1 kg and ''maintained weight'' will be defined as a loss of <500 g, or a gain of <1 kg.
Efficacy of mirtazapine in weight gain in patients with cachexia due to advanced cancer.''Improved'' weight will be defined as a gain of ≥ 1 kg and ''maintained'' will be defined as a loss of <500 g, or a gain of <1 kg.
Measured: It will be assessed at week 8 of receiving the intervention.
Effect of mirtazapine in improving other symptoms , such as : nausea , vomiting , sleep with a change of decrease of ≥ 2 points on the ESAS ( Edmonton Symptom Assessment Scale ) from baseline.
Effect of mirtazapine in improving other symptoms , such as : nausea , vomiting , sleep in patients with cachexia due to advanced cancer with a change of decrease of ≥ 2 points on the ESAS scale from baseline. The ESAS is both valid and reliable in the assessment of the intensity of symptoms in patients with cancer.
Measured: It will be assessed at week 8 of receiving the intervention.
Effect of mirtazapine in improving quality of life : will be measured by an increase of 16 points in the FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale .
Effect of mirtazapine in improving quality of life in patients with cachexia due to advanced cancer. This will be measured by an increase of 16 points in the FAACT which indicates ''improved'' quality of life. The FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale is internally consistent , reliable and valid as a measure of health-related quality of life for persons with advanced cancer.
We will contact their website to get the licence to use the questionnaire and to get its translated version.
Measured: It will be assessed at week 8 of receiving the intervention.
Changes in inflammatory cytokines associated with mirtazapine administration : quantitative c-reactive protein (CRP) , IL-6, and YKL-40 serum levels .
Changes in inflammatory cytokines associated with mirtazapine administration in patients with cachexia due to advanced cancer : quantitative c-reactive protein (CRP) and comparative analysis by enzyme-linked immunoassay (ELISA) will be performed on IL-6, and YKL-40 serum levels according to availability. They will be obtained at baseline (day 1 of treatment, immediately before first dose) and at week 8.
Measured: It will be assessed at week 8 of receiving the intervention.
Safety of mirtazapine use : Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Safety of mirtazapine use in patients with cachexia due to advanced cancer.Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. A traditional definition of dose-limiting toxicity (DLT) within the first cycle will be used (any grade 3 non-hematologic or grade 4 hematologic toxicity within 4 weeks and assessed as being at least possibly related to study drug).
A toxicity questionnaire will be done at baseline and then at 14-day intervals until day 28.
To fully assess the toxicity profile of the drug, the safety evaluation period in the trial will be extended 30 days from the date of the last dose of study drug.
Measured: It will be assessed at baseline , then at 14-day intervals until day 28 and after 30 days from the date of the last dose of the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start26 Mar 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Naseef Hunter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Naseef Hunter, Kasr El Aini Hospital
- Investigators
- Catherine N Hunter, Ass. lecturer, Principal investigator, Clinical Oncology Department at Kasr Al Ainy NEMROCK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254173
- Sponsor's protocol ID
- MCACS100
- Acronym
- MCACS100
- Status last verified
- Feb 2020
- First submitted
- 11 Jun 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be kept in records at clinical oncology department at Kasr Al Ainy NEMROCK to be available at anytime and shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia : a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03254173
- Acronym / sponsor ID
- MCACS100 / MCACS100
- Keywords
- Mirtazapine, Anorexia - Cachexia, Advanced Cancer, Appetite
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Catherine Naseef HunterUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 18 Aug 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.
A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.
Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer receiving mirtazapine 15 mg once daily for 8 weeks \& Arm B will involve another 50 patients with confirmed advanced cancer receiving placebo for 8 weeks.
Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation primarily and to assess other outcomes secondarily which will be discussed later in details.
Detailed description
- A Written consent is to be obtained from all patients before being enrolled in the study.
- Baseline Complete Blood Count , Liver function tests and kidney function tests will be obtained to assess safety to start the drug and to assess its dose adjustment.
- Two arms will be compared : mirtazapine oral 15mg daily versus placebo. This will be conducted on a double-blinded basis.
- Oral mirtazapine ( REMERON , RD , 30 mg tablets , Organon ) will be the original FDA approved drugs that will be used in the study.
- Treatment allocation will be concealed from patients, investigators, and study coordinators enrolling the participants.
- All patients will be counseled and given dietary advice by a dietician at baseline.
- Patients will be permitted to continue treatment at the same dose as scheduled as long as weight was stabilized (no loss greater than 10 % of body weight at baseline).
- Duration of therapy : Patients will remain on protocol for a duration of 8 weeks as long as they did not develop serious concurrent illness preventing further treatment, unacceptable adverse events (grade 3 or higher), the patient decides to withdraw from study, or the investigator judges that it is in the patient's best interest to discontinue treatment due to general or specific health conditions.
- Demographic data will include performance status, tumor type, sex, age, and percentage weight loss.
- The ESAS scale (Edmonton Symptom Assessment Scale ) will be used to assess the following 10 symptoms experienced by patients with cancer during the previous 24 hours:
- pain.
- Fatigue.
- Nausea.
- Depression.
- Anxiety.
- Drowsiness.
- Dyspnea.
- Anorexia.
- Sleep disturbance.
- And feelings of well-being.
The severity of each symptom is rated on a numerical scale of 0 to 10 (0_no symptom, 10_worst possible severity). The ESAS is both valid and reliable in the assessment of the intensity of symptoms in patients with cancer.
- The FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale will be used to assess quality of life among the studied patients , in a form of questionnaire including :
- Physical well-being.
- Social well-being.
- Emotional well-being.
- Functional well-being.
- Additional concerns. The patient rates the answer on a scale of 0 to 4. The FACIT - Pal scale is internally consistent , reliable and valid as a measure of health-related quality of life for persons with advanced cancer. We will contact their website to get the licence to use the questionnaire and to get its translated version.
- Anthropometric measures to assess efficacy of mirtazapine in weight gain :
- Assessment of weight of the patient .
- Assessment of muscle strength ( via hand grip dynamometry , using the device named Lite 200 lb , Fabrication Enterprises Incorporated Company).
- Assessment of lean ( via bioimpedance analysis , using the device named BF100 , Beurer Company ).
- Biological methods to assess efficacy of mirtazapine in modulating inflammatory cytokine media : quantitative c-reactive protein (CRP) and comparative analysis by enzyme-linked immunoassay (ELISA) will be performed on IL-6 ( Interleukin - 6 ) , and YKL-40 serum levels according to availability. They will be obtained at baseline (day 1 of treatment, immediately before first dose) and at week 8.
- Evaluation of safety and tolerability Patients who will receive at least one dose of study medication will be done.
- A traditional definition of dose-limiting toxicity (DLT) within the first cycle Will be used (any grade 3 non-hematologic or grade 4 hematologic toxicity within 4 weeks and assessed as being at least possibly related to study drug).
- A toxicity questionnaire will be done at baseline and then at 14-day intervals until day 28.
To fully assess the toxicity profile of the drug, the safety evaluation period in the trial will be extended 30 days from the date of the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blinded randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Mirtazapine 30 mg oral tabletsMirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets ) , as half tablet daily , i.e , 15mg daily , before sleep for a duration of 8 weeks |
| Arm B | Placebo comparator | Drug: Placebo oral tabletsPlacebo oral tablets , as half tablet daily before sleep for a duration of 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with confirmed advanced cancer.
- Patients with appetite score equal or more than 4 on a 0 to 10 scale (10 _ worst appetite).
- Patients with weight loss more than 5 % of body weight over 6 months . Or : Patients with any degree of weight loss more than 2 % associated with BMI ( body mass index ) of less than 20.
- Patients able to take pills orally and not dependent on tube feeding (no oral mucosal inflammation interfering with oral intake or dysphagia as determined by clinical examination).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (9 listed)
- Patients with weight gain for known cause , e.g. , ascites.
- Premenopausal women with childbearing potential with a positive pregnancy test.
- Patients unable to maintain oral intake .
- Patients with dementia or delirium.
- Patients with uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression will be excluded until their symptoms had stabilized for at least 2 weeks.
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 |
|---|---|---|
| Mirtazapine 30 mg oral tabletsAlso: Remeron 30 mg oral tabletsMirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets) , half tablet before sleep for 8 weeks | Drug | Arm A |
| Placebo oral tabletsPlacebo oral tablets , half tablet daily before sleep for 8 weeks | Drug | Arm B |
Primary outcome
Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase of 1.5 degree on a numerical scale of 0 -10 as a target .
Time frame: It will be assessed at week 4 of receiving the intervention. The 4-week duration of treatment is of sufficient length to obtain benefit from an effective intervention for appetite.
Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase 1.5 degree on a scale of 0-10 as a target , where 0 represents minimum appetite and 10 represents maximum appetite.
5 secondary outcomes
Efficacy of mirtazapine in weight gain. ''Improved'' weight will be defined as a gain of ≥ 1 kg and ''maintained weight'' will be defined as a loss of <500 g, or a gain of <1 kg.
Time frame: It will be assessed at week 8 of receiving the intervention.
Effect of mirtazapine in improving other symptoms , such as : nausea , vomiting , sleep with a change of decrease of ≥ 2 points on the ESAS ( Edmonton Symptom Assessment Scale ) from baseline.
Time frame: It will be assessed at week 8 of receiving the intervention.
Effect of mirtazapine in improving quality of life : will be measured by an increase of 16 points in the FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale .
Time frame: It will be assessed at week 8 of receiving the intervention.
Changes in inflammatory cytokines associated with mirtazapine administration : quantitative c-reactive protein (CRP) , IL-6, and YKL-40 serum levels .
Time frame: It will be assessed at week 8 of receiving the intervention.
Safety of mirtazapine use : Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Time frame: It will be assessed at baseline , then at 14-day intervals until day 28 and after 30 days from the date of the last dose of the study drug.
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 5 Feb 2020.
- Individual participant dataSharing planned: Yes. All data will be kept in records at clinical oncology department at Kasr Al Ainy NEMROCK to be available at anytime and shared with other researchers
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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.
Catherine N Hunter, Ass. lecturer principal investigator
Clinical Oncology Department at Kasr Al Ainy NEMROCK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mirtazapine 30 mg oral tablets in people with Advanced Cancer and Cancer Associated Anorexia - Cachexia, run by Catherine Naseef Hunter at 1 site in Egypt.
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 9 inclusion and 9 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 5 Feb 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase of 1.5 degree on a numerical scale of 0 -10 as a target . (time frame: It will be assessed at week 4 of receiving the intervention. The 4-week duration of treatment is of sufficient length to obtain benefit from an effective intervention for appetite.). 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 5 Feb 2020.