Clinical trial NCT03808805: Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
Official title: Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myeloproliferative Disorder
Aquagenic Pruritus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3, randomized prospective study, double blind-double placebo
Primary purpose: TREATMENT

Brief summary: Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

Detailed description: Identification of patients with myeloproliferative neoplasms and aquagenic pruritus. Evaluation of the intensity of the aquagenic pruritus. Patients with value \>5/10 on the VAS (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Eligibility criteria: Inclusion Criteria:

* Major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia or myelofibrosis)
* and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon, ruxolitinib or bled for more than 6 months
* and suffering of persistent aquagenic pruritus
* and with a pruritus intensity on Analogic Visual Scale \>5/10
* patients who gave their written consent for participation in the study

Exclusion Criteria:

* patients with a physical or psychological disability to sign the consent form
* patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but only treated by aspirin
* patients already included in another therapeutic protocol
* patients with diffuse dermatological disease where pruritus may be present (psoriasis, atopic dermatitis, prurigo
* patients already on anti-anxiety and / or anti-depressant treatment
* patients with absolute contraindications to the use of Aprepitant or Hydroxyzine
* hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients
* lactose intolerance
* pregnant or lactating women

Primary outcomes:
measure: Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
timeFrame: at 15 days
Secondary outcomes:
measure: Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
timeFrame: at 60 days
measure: Cessation of pruritus
timeFrame: at 15 days
measure: Cessation of pruritus
timeFrame: at 60 days
measure: Time observed to decreased the VAS to 3/10
timeFrame: 01 to 60 days
measure: Duration of treatment effectiveness
timeFrame: 1 to 60 days
measure: Adverse event occurring during the association therapeutic
timeFrame: at 15 days
measure: Number of prematurely discontinued anti-pruritic treatment
timeFrame: at 15 days
measure: Complete blood count (normal or abnormal)
timeFrame: 1 to 60 days
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
timeFrame: at J0 (day of inclusion)
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
timeFrame: at J0 (day of inclusion)
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
timeFrame: at 15 days
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
timeFrame: at 15 days
measure: Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
timeFrame: at 30 days
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
timeFrame: at 30 days
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
timeFrame: at 45 days
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
timeFrame: at 45 days
measure: Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
timeFrame: at 60 days
measure: Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
timeFrame: at 60 days
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
timeFrame: at J0 (day of inclusion)
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
timeFrame: at 15 days
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
timeFrame: at 30 days
measure: Quantification of the change of plasma concentrations of cytokines and neuropeptides
timeFrame: at 60 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
state: Brest Cedex
city: Angers
country: France
facility: CHU d'Angers
city: Caen
country: France
facility: CHU de Caen
city: Douarnenez
country: France
facility: Centre Hospitalier de Douarnenez
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Centre Léon Bérard
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
city: Nantes
country: France
facility: CHU de Nantes
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint-Brieuc
country: France
facility: Hôpital Yves Le Foll
Study officials:
affiliation: Hématologie Clinique-Institut de Cancéro-Hématologie
name: Jean-Christophe IANOTTO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Gall-Ianotto C, Verdet R, Nowak E, Le Roux L, Gasse A, Fiedler A, Carlhant-Kowalski D, Marcorelles P, Misery L, Ianotto JC. Rationale and design of the multicentric, double-blind, double-placebo, randomized trial APrepitant versus HYdroxyzine in association with cytoreductive treatments for patients with myeloproliferative neoplasia suffering from Persistent Aquagenic Pruritus. Trial acronym: APHYPAP. Trials. 2021 Dec 19;22(1):938. doi: 10.1186/s13063-021-05864-8.