Skin and Connective Tissue Diseases

Symptoms and General Pathology

All Conditions

Pruritus

Skin Diseases

Skin Manifestations

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Fosaprepitant

Aprepitant

Prednisone

Histamine Antagonists

Histamine H1 Antagonists

Diphenhydramine

Promethazine

Fexofenadine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Histamine

Histamine phosphate

Histamine H1 Antagonists, Non-Sedating

Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus

Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

125 mg on day 1; 80 mg on day 3; 80 mg on day 5

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Daniele Santini, MD, PhD

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients

Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period.

Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as \> 50% reduction of pruritus intensity compared to the baseline value.

Campus Bio-Medico University

MD, PhD

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Anti-Arrhythmia Agents

Channel Blockers

Vasoconstrictor Agents

Respiratory System Agents

Anesthetics

Lidocaine

Epinephrine

Racepinephrine

Epinephryl borate

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Lidocaine 1% c Epinephrine for local anesthesia

skin biopsy

Maria Hordinsky, MD

The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).

Little is known about the fundamental cause of pruritus in CTCL, however we do know the malignant CD4+ T-cells of CTCL accumulate in the epidermis and are in close proximity to the neural, immune and vascular systems that influence and regulate the biology of the skin. The close proximity of malignant CD4+ T-cells with the key mediators in the itch process could result in the pruritus experienced by patients with CTCL. To accomplish this we are collecting and examining skin biopsies for CTCL patients and healthy controls to identify itch-associated local biomarkers of the disease. In addition to these skin biopsies, we are retrospectively examining existing paraffin-embedded skin biopsy tissue blocks from CTCL patients. We are performing comparative and quantitative immunohistochemical analyses on the samples. This study will help to determine which components in the skin are potential key players in the manifestation and maintenance of recalcitrant pruritus in patients with CTCL.

Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

University of Minnesota

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aprepitant in the Management of Biological Therapies-related Severe Pruritus	NCT01683552	ITCH	Aprepitant Prednisone Fexofenadine	18 Years - 85 Years	Campus Bio-Medico University
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma	NCT00863395	Cutaneous T-Cel...	skin biopsy	18 Years -	University of Minnesota
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma	NCT00863395	Cutaneous T-Cel...	skin biopsy	18 Years -	University of Minnesota

Spots Global Cancer Trial Database for itch

Every month we try and update this database with for itch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for itch

Every month we try and update this database with for itch cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for itch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.