Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

Study Overview
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Brief Summary
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Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Detailed Description
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Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Official Title
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Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as acute leukemia, or lymphoma Patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment Without CNS involvement Without headache for at least 1 week before the day of lumbar puncture The platelet count was at least 30×10e9/L Exclusion Criteria: With CNS involvement of disease With headache before lumbar puncture Needs lumbar puncture more than once a week

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment. | Drug: Aprepitant<br>* use aprepitant 1 hour before lumbar puncture and intrathecal treatment<br>* Other names: Emend;|
| No Intervention: control arm<br>this arm will received nothing 1 hour before lumbar puncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of any grade post-lumbar-puncture headache |  | date from the day of lumbar puncture to 2 weeks after lumbar puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of grade 3/4 post-lumbar-puncture headache |  | date from the day of lumbar puncture to 2 weeks after lumbar puncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar puncture, leukemia, lymphoma, intrathecal treatment, post-lumbar puncture headache