Clinical trial NCT02347878: Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
Official title: Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leukemia
Lymphoma
Keywords: leukemia
lymphoma
lumbar puncture
intrathecal treatment
post-lumbar puncture headache
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of any grade post-lumbar-puncture headache
timeFrame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
Secondary outcomes:
measure: incidence of grade 3/4 post-lumbar-puncture headache
timeFrame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Liang Wang, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References: