Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms

University Hospital, Brest63 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myeloproliferative Disorder Aquagenic Pruritus

Interventions

Aprepitant 80 mgDRUG

oral therapy - daily dose - 14 days

Hydroxyzine 25mgDRUG

oral therapy - daily dose - 14 days

Placebo of HydroxyzineDRUG

oral therapy - daily dose - 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

CHRU de Brest - Hôpital Morvan

Brest, Brest Cedex, France

Centre Hospitalier de Cornouaille

Quimper, Quimper, France

CHU d'Angers

Angers, France

CHU de Caen

Caen, France

Outcomes

Primary Outcomes

Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )

number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)

Time frame: at 15 days

Secondary Outcomes

Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )

Time frame: at 60 days

Cessation of pruritus

number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms) )

Time frame: at 15 days

Cessation of pruritus

number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms))

Time frame: at 60 days

Time observed to decreased the VAS to 3/10

number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )

Time frame: 01 to 60 days

Duration of treatment effectiveness

number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10

Time frame: 1 to 60 days

Data from ClinicalTrials.gov

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oral therapy - daily dose - 14 days

Centre Hospitalier de Douarnenez

Douarnenez, France

CHU Grenoble Alpes

Grenoble, France

Centre Léon Bérard

Lyon, France

Centre Hospitalier des Pays de Morlaix

Morlaix, France

CHU de Nantes

Nantes, France

Hôpital Pontchaillou

Rennes, France

...and 1 more locations

Adverse event occurring during the association therapeutic

type of adverse event occuring during the treatment period

Time frame: at 15 days

Number of prematurely discontinued anti-pruritic treatment

Total number of prematurely discontinued treatments for all subjects

Time frame: at 15 days

Complete blood count (normal or abnormal)

number of patients with hematologic remission : hematocrit \<45% with leukocytes \<10 giga/l and platelets \<400 giga/l

Time frame: 1 to 60 days

Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire

Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire

Time frame: at J0 (day of inclusion)