Mirtazapine in Cancer-related Poly-symptomatology

NCT04763135 | Terminated Phase 3

• 2 other identifiers: 69HCL20_00322020-002994-90
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 11

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.

Conditions

Cancer; Neoplasms; Neoplasm Metastasis

Keywords

Cancer; Symptom management; Poly-Symptomatology; Mirtazapine; Antidepressive drugs

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and day 56

Secondary Outcomes (22)

• The subjective experience associated with symptoms burden.

  At baseline and day 56.

• Proportion of mitigated symptoms.

  Day 28

• Proportion of mitigated symptoms.

  Day 56

• Auto-assessment depression score.

  Day 28

• Auto-assessment depression score.

  Day 56

Study Arms (2)

Oral mirtazapine

EXPERIMENTAL

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.

Drug: Mirtazapine

Oral escitalopram

ACTIVE COMPARATOR

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.

Drug: Escitalopram

Interventions

Mirtazapine DRUG

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.

Oral mirtazapine

Escitalopram DRUG

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.

Oral escitalopram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (11)

Centre Hospitalier Universitaire de Clermont-Ferrand

Cébazat, 63118, France

Location

Centre Hospitalier Universitaire de Grenoble

La Tronche, 38700, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française

Lyon, 69005, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75005, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42100, France

Location

Hôpitaux universitaires de Strasbourg

Strasbourg, 67098, France

Location

Centre Hospitalier de Valence

Valence, 26000, France

Location

Related Publications (1)

• 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.

  PMID: 35599320 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Mirtazapine; Escitalopram

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring

Study Officials

• Guillaume ECONOMOS, MD

  Centre Hospitalier Lyon Sud - Service de Soins Palliatifs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: December 15, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

FR (11)