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

Phase 4

• Conditions: Leukemia; Lymphoma
• Interventions: Drug: Aprepitant

• Registration Number: NCT02347878
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-27
• Last Update Posted: 2015-01-27
• Study Start: 2015-04
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment arm	Aprepitant	this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.

Primary Outcome Measures

Name	Time	Method
incidence of any grade post-lumbar-puncture headache	date from the day of lumbar puncture to 2 weeks after lumbar puncture

Secondary Outcome Measures

Name	Time	Method
incidence of grade 3/4 post-lumbar-puncture headache	date from the day of lumbar puncture to 2 weeks after lumbar puncture

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China