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出境医 / 临床实验 / Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms (APHYPAP)
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms (APHYPAP)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myeloproliferative Disorder Aquagenic Pruritus | Drug: Aprepitant 80 mg Drug: Hydroxyzine 25mg Drug: Placebo of Hydroxyzine Drug: Placebo of Aprepitant | Phase 3 |
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase 3, randomized prospective study, double blind-double placebo |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus. |
| Actual Study Start Date : | April 16, 2019 |
| Estimated Primary Completion Date : | November 1, 2021 |
| Estimated Study Completion Date : | January 1, 2022 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- 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)
- 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) )
- 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))
- 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 )
- Duration of treatment effectiveness [ Time Frame: 1 to 60 days ]number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
- Adverse event occurring during the association therapeutic [ Time Frame: at 15 days ]type of adverse event occuring during the treatment period
- Number of prematurely discontinued anti-pruritic treatment [ Time Frame: at 15 days ]Total number of prematurely discontinued treatments for all subjects
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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)
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Jean-Christophe IANOTTO, MD, PhD | 02 98 22 37 86 ext +33 | jean-christophe.ianotto@chu-brest.fr |
Locations
| France | |
| CHRU de Brest - Hôpital Morvan | Recruiting |
| Brest, Brest Cedex, France, 29609 | |
| Contact: Jean-Christophe IANOTTO, Pr 02 98 22 37 86 jean-christophe.ianotto@chu-brest.fr | |
| CHU d'Angers | Recruiting |
| Angers, France, 49933 | |
| Contact: Françoise BOYER, Dr 02 41 35 54 50 FrBoyer-Perrard@chu-angers.fr | |
| CHU de Caen | Recruiting |
| Caen, France, 14033 | |
| Contact: Gandhi Laurent DAMAJ, Pr 0231272140 damaj-gl@chu-caen.fr | |
| Centre Hospitalier de Douarnenez | Not yet recruiting |
| Douarnenez, France, 29171 | |
| Contact: Anne-Sophie LE BRIS-MICHEL, Dr 02 98 75 15 85 as.lebris@ch-douarnenez.fr | |
| CHU Grenoble Alpes | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Frédéric GARBAN, Pr 0476765661 FGarban@chu-grenoble.fr | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Franck NICOLINI, Dr 0469856193 Franck-Emmanuel.NICOLINI@lyon.unicancer.fr | |
| Centre Hospitalier des Pays de Morlaix | Not yet recruiting |
| Morlaix, France, 29672 | |
| Contact: Mohamed MALOU, Pr 02 98 62 60 38 mmalou@ch-morlaix.fr | |
| CHU de Nantes | Recruiting |
| Nantes, France, 44093 | |
| Contact: Viviane DUBRUILLE, Dr 02 40 08 32 81 viviane.dubruille@chu-nantes.fr | |
| Centre Hospitalier de Cornouaille | Recruiting |
| Quimper, France, 29107 | |
| Contact: Pascal HUTIN, Dr 02 98 52 61 50 ext +33 p.hutin@ch-cornouaille.fr | |
| Hôpital Pontchaillou | Recruiting |
| Rennes, France | |
| Contact: Marc BERNARD, Dr 0299284292 marc.bernard@chu-rennes.fr | |
| Hôpital Yves Le Foll | Not yet recruiting |
| Saint-Brieuc, France, 22027 | |
| Contact: Iuliana MARTINIUC 02 96 01 75 87 iuliana.martiniuc@ch-stbrieuc.fr | |
Sponsors and Collaborators
University Hospital, Brest
Investigators
| Principal Investigator: | Jean-Christophe IANOTTO, MD, PhD | Hématologie Clinique-Institut de Cancéro-Hématologie |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | September 26, 2018 | ||||
| First Posted Date ICMJE | January 18, 2019 | ||||
| Last Update Posted Date | June 11, 2021 | ||||
| Actual Study Start Date ICMJE | April 16, 2019 | ||||
| Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms | ||||
| Official Title ICMJE | Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus. | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Phase 3, randomized prospective study, double blind-double placebo Masking: Single (Participant)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
80 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 1, 2022 | ||||
| Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03808805 | ||||
| Other Study ID Numbers ICMJE | ApHyPAP 29BRC18.0036 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Brest | ||||
| Study Sponsor ICMJE | University Hospital, Brest | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Brest | ||||
| Verification Date | June 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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