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

June 10, 2021 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
      • Douarnenez, France, 29171
        • Not yet recruiting
        • Centre Hospitalier de Douarnenez
        • Contact:
      • Grenoble, France, 38043
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
      • Lyon, France, 69373
      • Morlaix, France, 29672
        • Not yet recruiting
        • Centre hospitalier des pays de Morlaix
        • Contact:
      • Nantes, France, 44093
      • Quimper, France, 29107
        • Recruiting
        • Centre Hospitalier de Cornouaille
        • Contact:
      • Rennes, France
      • Saint-Brieuc, France, 22027
    • Brest Cedex
      • Brest, Brest Cedex, France, 29609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: studied group
Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
Drug: Aprepitant 80 mg
oral therapy - daily dose - 14 days
Drug: Placebo of Hydroxyzine
oral therapy - daily dose - 14 days
Active Comparator: comparative group
Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
Drug: Hydroxyzine 25mg
oral therapy - daily dose - 14 days
Drug: Placebo of Aprepitant
oral therapy - daily dose - 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Time Frame: 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)
at 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Time Frame: 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)
at 60 days
Cessation of pruritus
Time Frame: at 15 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) )
at 15 days
Cessation of pruritus
Time Frame: 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))
at 60 days
Time observed to decreased the VAS to 3/10
Time Frame: 01 to 60 days
number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )
01 to 60 days
Duration of treatment effectiveness
Time Frame: 1 to 60 days
number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
1 to 60 days
Adverse event occurring during the association therapeutic
Time Frame: at 15 days
type of adverse event occuring during the treatment period
at 15 days
Number of prematurely discontinued anti-pruritic treatment
Time Frame: at 15 days
Total number of prematurely discontinued treatments for all subjects
at 15 days
Complete blood count (normal or abnormal)
Time Frame: 1 to 60 days
number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l
1 to 60 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time Frame: at J0 (day of inclusion)
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)
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time Frame: at J0 (day of inclusion)
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)
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time Frame: at 15 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
at 15 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time Frame: at 15 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
at 15 days
Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time Frame: 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
at 30 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time Frame: at 30 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
at 30 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time Frame: at 45 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
at 45 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time Frame: at 45 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
at 45 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time Frame: 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
at 60 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time Frame: 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
at 60 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time Frame: at J0 (day of inclusion)
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
at J0 (day of inclusion)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time Frame: at 15 days
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
at 15 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time Frame: at 30 days
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
at 30 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time Frame: at 60 days
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
at 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Jean-Christophe IANOTTO, MD, PhD, Hématologie Clinique-Institut de Cancéro-Hématologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ApHyPAP 29BRC18.0036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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