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

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Allergic Agents

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Desloratadine

Loratadine

Cholinergic Antagonists

Cholinergic Agents

Histamine H1 Antagonists, Non-Sedating

Tyrosine

aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;

placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28

aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Placebo of aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Placebo of aprepitant

Placebo of desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Placebo of desloratadine

Li Zhang, professor

Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. VAS investigation will be taken once a week to treatment end (4 weeks).

This is a prospective, randomized control, double-blinded, phase II clinical trial. Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment (1 week) compared to baseline score. The VAS inquiry will be taken once a week for 4 weeks. Quality of life investigation will be performed at baseline, 1 week and 4 weeks after treatment using SKINDEX-16 questionnaire. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender,and VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. Aprepitant arm will be administrated aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28; desloratadine arm will be administrated placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28. Tolerance evaluation will be taken according to National Cancer Institute (NCI)-Common Terminology Criteria (CTC) For Adverse Events (AE) V4.03.

Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

Aprepitant vs. Desloratadine in Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Related Pruritus: A Prospective, Randomized Control, Double-blinded, Phase II Clinical Trial

effective treatment of pruritus relieving defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score

the time from pruritus effective relief to VAS score increase ≥ baseline level, the VAS inquiry will be taken once a week.

using SKINDEX-16 questionnaire to assess patients quality of life

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
Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment	NCT02646020	Non-small Cell ...	Aprepitant Desloratadine Placebo of apre... Placebo of desl...	18 Years -	Sun Yat-sen University
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 placebo of aprepitant