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

Primary Purpose

Myeloproliferative Disorder, Aquagenic Pruritus

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Aprepitant 80 mg
Hydroxyzine 25mg
Placebo of Hydroxyzine
Placebo of Aprepitant
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloproliferative Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Brest - Hôpital MorvanRecruiting
  • CHU d'AngersRecruiting
  • CHU de CaenRecruiting
  • Centre Hospitalier de Douarnenez
  • CHU Grenoble AlpesRecruiting
  • Centre Léon BérardRecruiting
  • Centre Hospitalier des Pays de Morlaix
  • CHU de NantesRecruiting
  • Centre Hospitalier de CornouailleRecruiting
  • Hôpital PontchaillouRecruiting
  • Hôpital Yves Le Foll

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

studied group

comparative group

Arm Description

Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days

Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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) )
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 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 )
Duration of treatment effectiveness
number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
Adverse event occurring during the association therapeutic
type of adverse event occuring during the treatment period
Number of prematurely discontinued anti-pruritic treatment
Total number of prematurely discontinued treatments for all subjects
Complete blood count (normal or abnormal)
number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l
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
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
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
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
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
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
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
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
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
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
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)

Full Information

First Posted
September 26, 2018
Last Updated
June 10, 2021
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03808805
Brief Title
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
Acronym
APHYPAP
Official Title
Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloproliferative Disorder, Aquagenic Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3, randomized prospective study, double blind-double placebo
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
studied group
Arm Type
Experimental
Arm Description
Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
Arm Title
comparative group
Arm Type
Active Comparator
Arm Description
Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
Intervention Type
Drug
Intervention Name(s)
Aprepitant 80 mg
Intervention Description
oral therapy - daily dose - 14 days
Intervention Type
Drug
Intervention Name(s)
Hydroxyzine 25mg
Intervention Description
oral therapy - daily dose - 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo of Hydroxyzine
Intervention Description
oral therapy - daily dose - 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo of Aprepitant
Intervention Description
oral therapy - daily dose - 14 days
Primary Outcome Measure Information:
Title
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Description
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 Outcome Measure Information:
Title
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Description
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 60 days
Title
Cessation of pruritus
Description
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
Title
Cessation of pruritus
Description
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
Title
Time observed to decreased the VAS to 3/10
Description
number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )
Time Frame
01 to 60 days
Title
Duration of treatment effectiveness
Description
number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
Time Frame
1 to 60 days
Title
Adverse event occurring during the association therapeutic
Description
type of adverse event occuring during the treatment period
Time Frame
at 15 days
Title
Number of prematurely discontinued anti-pruritic treatment
Description
Total number of prematurely discontinued treatments for all subjects
Time Frame
at 15 days
Title
Complete blood count (normal or abnormal)
Description
number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l
Time Frame
1 to 60 days
Title
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Description
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)
Title
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Description
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
Time Frame
at J0 (day of inclusion)
Title
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Description
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 15 days
Title
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Description
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
Time Frame
at 15 days
Title
Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Description
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 30 days
Title
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Description
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
Time Frame
at 30 days
Title
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Description
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 45 days
Title
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Description
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
Time Frame
at 45 days
Title
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Description
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 60 days
Title
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Description
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
Time Frame
at 60 days
Title
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Description
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Time Frame
at J0 (day of inclusion)
Title
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Description
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Time Frame
at 15 days
Title
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Description
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Time Frame
at 30 days
Title
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Description
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Time Frame
at 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe IANOTTO, MD, PhD
Phone
02 98 22 37 86
Ext
+33
Email
jean-christophe.ianotto@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe IANOTTO, MD, PhD
Organizational Affiliation
Hématologie Clinique-Institut de Cancéro-Hématologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest
State/Province
Brest Cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe IANOTTO, Pr
Phone
02 98 22 37 86
Email
jean-christophe.ianotto@chu-brest.fr
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise BOYER, Dr
Phone
02 41 35 54 50
Email
FrBoyer-Perrard@chu-angers.fr
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gandhi Laurent DAMAJ, Pr
Phone
0231272140
Email
damaj-gl@chu-caen.fr
Facility Name
Centre Hospitalier de Douarnenez
City
Douarnenez
ZIP/Postal Code
29171
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie LE BRIS-MICHEL, Dr
Phone
02 98 75 15 85
Email
as.lebris@ch-douarnenez.fr
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric GARBAN, Pr
Phone
0476765661
Email
FGarban@chu-grenoble.fr
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck NICOLINI, Dr
Phone
0469856193
Email
Franck-Emmanuel.NICOLINI@lyon.unicancer.fr
Facility Name
Centre Hospitalier des Pays de Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed MALOU, Pr
Phone
02 98 62 60 38
Email
mmalou@ch-morlaix.fr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane DUBRUILLE, Dr
Phone
02 40 08 32 81
Email
viviane.dubruille@chu-nantes.fr
Facility Name
Centre Hospitalier de Cornouaille
City
Quimper
ZIP/Postal Code
29107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal HUTIN, Dr
Phone
02 98 52 61 50
Ext
+33
Email
p.hutin@ch-cornouaille.fr
Facility Name
Hôpital Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BERNARD, Dr
Phone
0299284292
Email
marc.bernard@chu-rennes.fr
Facility Name
Hôpital Yves Le Foll
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iuliana MARTINIUC
Phone
02 96 01 75 87
Email
iuliana.martiniuc@ch-stbrieuc.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34923994
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.
Results Reference
derived

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

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