Year: 2018
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Crossover Clinical TrialPruritus may impair quality of life in patients with Sézary syndrome, the leukemic variant of cutaneous T-cell lymphomas.Management of pruritus is challenging and often unsatisfactory.Retrospective reports have found aprepitant, a neurokinin 1 receptor antagonist approved for the treatment of chemotherapy-induced or postoperative emesis, to show some efficacy in managing pruritus in patients with cutaneous T-cell lymphoma.[1][2][3][4][5] We conducted a randomized, double-blind, placebocontrolled crossover study in patients with Sézary syndrome to test the hypothesis that treatment with the neurokinin 1 receptor antagonist aprepitant would decrease pruritus. Methods | Patients seen in the Vanderbilt University Cutaneous Lymphoma clinic meeting the International Society forCutaneous Lymphomas-European Organisation for Research and Treatment of Cancer criteria 6 for Sézary syndrome were eligible.Patients with Sézary syndrome with uncontrolled pruritus and a baseline visual analog scale for pruritus of greater than 40 mm were eligible.Participants were also required to be on a stable medication regimen for Sézary syndrome and a stable antipruritic medication regimen for 3 months prior to the study.Written informed consent was obtained and the protocol was approved by the Vanderbilt Institutional Review Board and carried out according to the Declaration of Helsinki.The study protocol is available in the Supplement.Placebo or aprepitant (125 mg on day 1, followed by 80 mg on days 2-7) was ingested daily for 7 days followed by a 1-week washout period before taking the other treatment.The primary outcome measure was severity of pruritus measured using a visual analog scale of 0 to 100 mm (worst pruritus imaginable).The secondary outcome measure was quality of life using the Dermatology Life Quality Index instrument.Mixed-effect models were used to analyze the data with a random subject effect and with treatment (aprepitant vs placebo) and time as fixed effects; baseline pruritus by visual analog scale was included as a covariate.Paired comparisons at specific time points or between time points were made using a Wilcoxon signed-rank test.Hypotheses were tested at the level of α = .05.
Source: JAMA Dermatology
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2888346002