Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
- Conditions
- Myeloproliferative DisorderAquagenic Pruritus
- Interventions
- Registration Number
- NCT03808805
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description studied group Placebo of Hydroxyzine Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days comparative group Hydroxyzine 25mg Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days comparative group Placebo of Aprepitant Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days studied group Aprepitant 80 mg Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
- Primary Outcome Measures
Name Time Method Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale ) at 15 days 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)
- Secondary Outcome Measures
Name Time Method Time observed to decreased the VAS to 3/10 01 to 60 days number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale ) at 60 days 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)
Cessation of pruritus at 60 days 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))
Duration of treatment effectiveness 1 to 60 days number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire at 60 days Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire at 30 days 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
Adverse event occurring during the association therapeutic at 15 days type of adverse event occuring during the treatment period
Complete blood count (normal or abnormal) 1 to 60 days number of patients with hematologic remission : hematocrit \<45% with leukocytes \<10 giga/l and platelets \<400 giga/l
Number of prematurely discontinued anti-pruritic treatment at 15 days Total number of prematurely discontinued treatments for all subjects
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire at 60 days 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
Quantification of the change of plasma concentrations of cytokines and neuropeptides at 60 days Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Trial Locations
- Locations (11)
CHU d'Angers
🇫🇷Angers, France
Centre Hospitalier des Pays de Morlaix
🇫🇷Morlaix, France
Hôpital Yves Le Foll
🇫🇷Saint-Brieuc, France
Hôpital Pontchaillou
🇫🇷Rennes, France
Centre Léon Bérard
🇫🇷Lyon, France
CHU de Caen
🇫🇷Caen, France
Centre Hospitalier de Douarnenez
🇫🇷Douarnenez, France
CHU Grenoble Alpes
🇫🇷Grenoble, France
CHU de Nantes
🇫🇷Nantes, France
Centre Hospitalier de Cornouaille
🇫🇷Quimper, France
CHRU de Brest - Hôpital Morvan
🇫🇷Brest, Brest Cedex, France