search
Back to results

Mirtazapine in Cancer-related Poly-symptomatology (MIR-P)

Primary Purpose

Cancer, Neoplasms, Neoplasm Metastasis

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mirtazapine
Escitalopram
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Symptom management, Poly-Symptomatology, Mirtazapine, Antidepressive drugs

Eligibility Criteria

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

Inclusion Criteria:

  • Being over 18 years old
  • Suffering from advanced cancer
  • Having a clinically estimated life expectancy over 3 months.
  • Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11.
  • Being in need of an antidepressant treatment.
  • Suffering from at least one under-controlled symptom (defined as a score over 3 on the Edmonton Symptom Assessment Scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing.
  • Having or not a cancer treatment.
  • Being able to understand the information related to the study, and to sign informed consent.
  • Having agreed to take part to the study.
  • Being able to fill Patient Reported Outcomes questionnaires.
  • Being available to be call on days 7 and 14.
  • Having a social security affiliation.

Exclusion Criteria:

  • Being treated by an antidepressive agent during the four weeks before inclusion.
  • Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient.
  • Having had a prior inefficient treatment by mirtazapine or escitalopram.
  • Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology
  • Having a QT interval over 420 ms.
  • Having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder.
  • Having had or having bipolar disorder.
  • Having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion)
  • Having or having history of closed-angle glaucoma.
  • Having bone marrow aplasia.
  • Practicing breast-feeding or being pregnant.
  • Women of childbearing age with no contraception method.
  • Having a treatment with:
  • Monoamine oxidase inhibitors (Selegiline, Moclobemide, Isocarboxazid, Nialamide, Phenelzine, Tranylcypromine, Iproniazid, Iproclozide, Toloxatone, Linezolid, Safinamide, Rasagiline)
  • One of the following antiarrhythmic drugs: Flecainide, Propafenone, any class IA and III antiarrhythmic drug (amiodarone, disopyramide, hydroquinidine, quinidine, procainamide, sparteine, ajmaline, prajmaline, lorajmine, bretylium tosilate, bunaftine, dofetilide, ibutilide, tedisamil, dronedarone).
  • Antipsychotic drugs (phenothiazine antipsychotics, pimozide, haloperidol)
  • Linezolid, sparfloxacin, moxifloxacin, macrolides (IV erythromycin, josamycin, clarithromycin, telithromycin), pentamidin, halofantrine, HIV protease inhibitors (ritonavir, nelfinavir, amprenavir, indinavir), azolic antifungal agents (ketoconazole, itraconazole, miconazole, fluconazole, voriconazole)
  • Mizolastine and Cimetidine
  • Ticlopidine
  • Metoprolol
  • Methadone
  • Ketamine
  • Triptan drugs
  • Dapoxetine
  • St. John's wort
  • Antidepressant drug
  • Any other medication known to cause prolonged QT intervals.
  • Having genetic galactose intolerance or glucose-galactose malabsorption.
  • Having one of the following electrolyte disorders not corrected at the time of inclusion: hyponatremia, hyperkalemia, hypokalemia, hypermagnesemia, and hypomagnesemia.
  • Having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the Cockroft's formula.
  • Having hepatic failure.
  • Having legal incapacity

Sites / Locations

  • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Centre Hospitalier Universitaire de Grenoble
  • Hôpital Edouard Herriot
  • Hôpital de la Croix-Rousse
  • Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française
  • Centre Léon Bérard
  • Institut Curie
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Saint-Etienne
  • Hôpitaux universitaires de Strasbourg
  • Centre Hospitalier de Valence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral mirtazapine

Oral escitalopram

Arm Description

Arm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure.

Arm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients.

Outcomes

Primary Outcome Measures

Global health status score
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale. The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.

Secondary Outcome Measures

The subjective experience associated with symptoms burden.
Qualitative analysis of compared semi-structured interviews undertaken at baseline and day 56 on a convenience sample.
Proportion of mitigated symptoms.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Proportion of mitigated symptoms.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Auto-assessment depression score.
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Auto-assessment depression score.
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Hetero-assessment-based depression score.
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Hetero-assessment-based depression score.
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Weight control
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time.
Weight control
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time.
Weight improvement.
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Weight improvement.
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Stability in oral morphine milligram equivalents.
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Stability in oral morphine milligram equivalents.
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Escalation in symptom control treatment doses
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Escalation in symptom control treatment doses
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Medication adherence.
The medication adherence will be assessed using the Medication Adherence Rating Scale score at day 56 and the Proportion of Days Covered all along the follow-up period.
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.

Full Information

First Posted
February 15, 2021
Last Updated
June 7, 2023
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT04763135
Brief Title
Mirtazapine in Cancer-related Poly-symptomatology
Acronym
MIR-P
Official Title
What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
difficulties in recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Neoplasms, Neoplasm Metastasis
Keywords
Cancer, Symptom management, Poly-Symptomatology, Mirtazapine, Antidepressive drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral mirtazapine
Arm Type
Experimental
Arm Description
Arm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure.
Arm Title
Oral escitalopram
Arm Type
Active Comparator
Arm Description
Arm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients.
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Orally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Orally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment.
Primary Outcome Measure Information:
Title
Global health status score
Description
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale. The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.
Time Frame
At baseline and day 56
Secondary Outcome Measure Information:
Title
The subjective experience associated with symptoms burden.
Description
Qualitative analysis of compared semi-structured interviews undertaken at baseline and day 56 on a convenience sample.
Time Frame
At baseline and day 56.
Title
Proportion of mitigated symptoms.
Description
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Time Frame
Day 28
Title
Proportion of mitigated symptoms.
Description
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Time Frame
Day 56
Title
Auto-assessment depression score.
Description
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Time Frame
Day 28
Title
Auto-assessment depression score.
Description
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Time Frame
Day 56
Title
Hetero-assessment-based depression score.
Description
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Time Frame
Day 28
Title
Hetero-assessment-based depression score.
Description
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Time Frame
Day 56
Title
Weight control
Description
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time.
Time Frame
Day 28
Title
Weight control
Description
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time.
Time Frame
Day 56
Title
Weight improvement.
Description
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Time Frame
Day 28
Title
Weight improvement.
Description
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Time Frame
Day 56
Title
Stability in oral morphine milligram equivalents.
Description
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Time Frame
Day 28
Title
Stability in oral morphine milligram equivalents.
Description
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Time Frame
Day 56
Title
Escalation in symptom control treatment doses
Description
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Time Frame
Day 28
Title
Escalation in symptom control treatment doses
Description
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Time Frame
Day 56
Title
Number of side effects.
Description
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Time Frame
Day 7
Title
Number of side effects.
Description
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Time Frame
Day 14
Title
Number of side effects.
Description
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Time Frame
Day 28
Title
Number of side effects.
Description
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Time Frame
Day 56
Title
Medication adherence.
Description
The medication adherence will be assessed using the Medication Adherence Rating Scale score at day 56 and the Proportion of Days Covered all along the follow-up period.
Time Frame
Day 56
Title
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Description
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.
Time Frame
Day 28
Title
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Description
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being over 18 years old Suffering from advanced cancer Having a clinically estimated life expectancy over 3 months. Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11. Being in need of an antidepressant treatment. Suffering from at least one under-controlled symptom (defined as a score over 3 on the Edmonton Symptom Assessment Scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing. Having or not a cancer treatment. Being able to understand the information related to the study, and to sign informed consent. Having agreed to take part to the study. Being able to fill Patient Reported Outcomes questionnaires. Being available to be call on days 7 and 14. Having a social security affiliation. Exclusion Criteria: Being treated by an antidepressive agent during the four weeks before inclusion. Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient. Having had a prior inefficient treatment by mirtazapine or escitalopram. Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology Having a QT interval over 420 ms. Having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder. Having had or having bipolar disorder. Having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion) Having or having history of closed-angle glaucoma. Having bone marrow aplasia. Practicing breast-feeding or being pregnant. Women of childbearing age with no contraception method. Having a treatment with: Monoamine oxidase inhibitors (Selegiline, Moclobemide, Isocarboxazid, Nialamide, Phenelzine, Tranylcypromine, Iproniazid, Iproclozide, Toloxatone, Linezolid, Safinamide, Rasagiline) One of the following antiarrhythmic drugs: Flecainide, Propafenone, any class IA and III antiarrhythmic drug (amiodarone, disopyramide, hydroquinidine, quinidine, procainamide, sparteine, ajmaline, prajmaline, lorajmine, bretylium tosilate, bunaftine, dofetilide, ibutilide, tedisamil, dronedarone). Linezolid, sparfloxacin, moxifloxacin, macrolides (IV erythromycin, josamycin, clarithromycin, telithromycin), pentamidin, halofantrine, HIV protease inhibitors (ritonavir, nelfinavir, amprenavir, indinavir), azolic antifungal agents (ketoconazole, itraconazole, miconazole, fluconazole, voriconazole) Mizolastine and Astémizole St. John's wort Having genetic galactose intolerance or glucose-galactose malabsorption. Having one of the following electrolyte disorders not corrected at the time of inclusion: hyponatremia, hyperkalemia, hypokalemia, hypermagnesemia, and hypomagnesemia. Having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the Cockroft's formula. Having hepatic failure. Having legal incapacity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume ECONOMOS, MD
Organizational Affiliation
Centre Hospitalier Lyon Sud - Service de Soins Palliatifs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Cébazat
ZIP/Postal Code
63118
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française
City
Lyon
ZIP/Postal Code
69005
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Facility Name
Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35599320
Citation
Economos G, Alexandre M, Perceau-Chambard E, Villeneuve L, Subtil F, Haesebaert J, Glehen O. What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol. BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7.
Results Reference
derived

Learn more about this trial

Mirtazapine in Cancer-related Poly-symptomatology

We'll reach out to this number within 24 hrs