Pruritus, Sezary Syndrome
Conditions
Keywords
Sezary Syndrome, Pruritus, Aprepitant, Neurokinin-1
Brief summary
The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.
Interventions
DRUGAprepitant
Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
DRUGPlacebo
Placebo will be given orally for a total of 7 days.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Known Sezary Syndrome * Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale \> 4. * Age 18 through 80 years of age. * Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to study participation.
Exclusion criteria
* Known hepatic impairment (defined as liver function tests \>3 times the upper limit of normal). * Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing). * Concurrent use of pimozide, terfenadine, astemizole, or cisapride.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Pruritus | one week | The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | one week | The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI). For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life. Maximum response for all ten questions 30, minimum 0. |
Countries
United States
Participant flow
Pre-assignment details
Seven subjects were consented and enrolled. Two did not meet inclusion/exclusion criteria and were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then Aprepitant These subjects received placebo during the first week and then crossed over to aprepitant for the second week. | 2 |
| Aprepitant Then Placebo. These subjects received aprepitant during the first week and then crossed over to placebo for the second week. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Aprepitant Then Placebo. | Placebo Then Aprepitant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Continuous | 58.3 years | 71 years | 63.4 years |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Severity of Pruritus
The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.
Time frame: one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Severity of Pruritus | 58.20 units on a scale | Standard Deviation 17.82 |
| Placebo | Severity of Pruritus | 47.47 units on a scale | Standard Deviation 20.22 |
Secondary
Quality of Life
The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI). For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life. Maximum response for all ten questions 30, minimum 0.
Time frame: one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Quality of Life | 14.2 scores on a scale | Standard Deviation 9.7 |
| Placebo | Quality of Life | 14.8 scores on a scale | Standard Deviation 10.3 |