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NCT Number: NCT03808805

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

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.

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Key information

Conditions

Myeloproliferative Disorder Aquagenic Pruritus Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU de Brest - Hôpital Morvan, Brest, Brest Cedex, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant 80 mg

Drug

oral therapy - daily dose - 14 days

Hydroxyzine 25mg

Drug

oral therapy - daily dose - 14 days

Placebo of Hydroxyzine

Drug

oral therapy - daily dose - 14 days

Placebo of Aprepitant

Drug

oral therapy - daily dose - 14 days

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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) )

  3. 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))

  4. 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 )

  5. Duration of treatment effectiveness

    Time frame: 1 to 60 days

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

  6. Adverse event occurring during the association therapeutic

    Time frame: at 15 days

    type of adverse event occuring during the treatment period

  7. Number of prematurely discontinued anti-pruritic treatment

    Time frame: at 15 days

    Total number of prematurely discontinued treatments for all subjects

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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)

  20. 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)

  21. 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)

  22. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: APHYPAP

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jan 18, 2019
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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