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

Myeloproliferative Disorder Clinical Trial

— APHYPAP  

Official title:

Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808805
• Other study ID #: ApHyPAP 29BRC18.0036
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: June 2021
• Source: University Hospital, Brest
• Contact: Jean-Christophe IANOTTO, MD, PhD
• Phone: 02 98 22 37 86
• Email: jean-christophe.ianotto[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia or myelofibrosis)
• and treated with hydroxyurea, pipobroman, anagrelide, a2a 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

Related Conditions & MeSH terms

• Aquagenic Pruritus
• Myeloproliferative Disorder
• Myeloproliferative Disorders
• Pruritus

Intervention

Drug:
• Aprepitant 80 mg
oral therapy - daily dose - 14 days
• Hydroxyzine 25mg
oral therapy - daily dose - 14 days
• Placebo of Hydroxyzine
oral therapy - daily dose - 14 days
• Placebo of Aprepitant
oral therapy - daily dose - 14 days

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHRU de Brest - Hôpital Morvan	Brest	Brest Cedex
France	CHU de Caen	Caen
France	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	Centre Hospitalier de Cornouaille	Quimper
France	Hôpital Pontchaillou	Rennes
France	Hôpital Yves Le Foll	Saint-Brieuc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at 15 days
Secondary	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)	at 60 days
Secondary	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) )	at 15 days
Secondary	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))	at 60 days
Secondary	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 )	01 to 60 days
Secondary	Duration of treatment effectiveness	number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10	1 to 60 days
Secondary	Adverse event occurring during the association therapeutic	type of adverse event occuring during the treatment period	at 15 days
Secondary	Number of prematurely discontinued anti-pruritic treatment	Total number of prematurely discontinued treatments for all subjects	at 15 days
Secondary	Complete blood count (normal or abnormal)	number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l	1 to 60 days
Secondary	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	at J0 (day of inclusion)
Secondary	Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire	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	at J0 (day of inclusion)
Secondary	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	at 15 days
Secondary	Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire	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	at 15 days
Secondary	Quality of life through the use of validated questionnaires : 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	at 30 days
Secondary	Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire	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	at 30 days
Secondary	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	at 45 days
Secondary	Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire	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	at 45 days
Secondary	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	at 60 days
Secondary	Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire	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	at 60 days
Secondary	Quantification of the change of plasma concentrations of cytokines and neuropeptides	Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)	at J0 (day of inclusion)
Secondary	Quantification of the change of plasma concentrations of cytokines and neuropeptides	Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)	at 15 days
Secondary	Quantification of the change of plasma concentrations of cytokines and neuropeptides	Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)	at 30 days
Secondary	Quantification of the change of plasma concentrations of cytokines and neuropeptides	Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)	at 60 days