Skin and Connective Tissue Diseases

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Rare Diseases

Pruritus

Myeloproliferative Disorders

Skin Diseases

Skin Manifestations

Bone Marrow Diseases

Hematologic Diseases

Chronic Myeloproliferative Disorders

Aquagenic Pruritus

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Aprepitant

Hydroxyzine

Fosaprepitant

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

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

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

Aprepitant 80 mg

Hydroxyzine 25mg

Placebo of Hydroxyzine

Placebo of Aprepitant

Jean-Christophe IANOTTO, MD, PhD

Jean-Christophe IANOTTO, Pr

Françoise BOYER, Dr

Gandhi Laurent DAMAJ, Pr

Anne-Sophie LE BRIS-MICHEL, Dr

Frédéric GARBAN, Pr

Franck NICOLINI, Dr

Mohamed MALOU, Pr

Viviane DUBRUILLE, Dr

Pascal HUTIN, Dr

Marc BERNARD, Dr

Iuliana MARTINIUC

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.

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.

Phase 3, randomized prospective study, double blind-double placebo

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

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

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)

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) )

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))

number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )

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

type of adverse event occuring during the treatment period

Total number of prematurely discontinued treatments for all subjects

number of patients with hematologic remission : hematocrit \<45% with leukocytes \<10 giga/l and platelets \<400 giga/l

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

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

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

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

Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)

University Hospital, Brest

Immune System Diseases

Syndrome

Lupus Erythematosus, Systemic

IANOTTO Jean-Christophe, MD, PhD

Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.

Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.

Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms

Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)

Analogic Visual Scale, from 0 to 10, Worse if \>6

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms	NCT03808805	Myeloproliferat... Aquagenic Pruri...	Aprepitant 80 m... Hydroxyzine 25m... Placebo of Hydr... Placebo of Apre...	18 Years -	University Hospital, Brest
Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms	NCT03688490	Myeloproliferat...		-	University Hospital, Brest
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms	NCT03808805	Myeloproliferat... Aquagenic Pruri...	Aprepitant 80 m... Hydroxyzine 25m... Placebo of Hydr... Placebo of Apre...	18 Years -	University Hospital, Brest

Spots Global Cancer Trial Database for aquagenic pruritus