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

NCT ID: NCT02347878

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

treatment arm

this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

use aprepitant 1 hour before lumbar puncture and intrathecal treatment

control arm

this arm will received nothing 1 hour before lumbar puncture

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aprepitant

use aprepitant 1 hour before lumbar puncture and intrathecal treatment

Intervention Type: DRUG

Other Intervention Names

Emend

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Liang Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Wang, DOCTOR

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Liang Wang, doctor

Role: CONTACT

wangliang@sysucc.org.cn

+86-20-87342462

Facility Contacts

Liang Wang, Doctor

Role: primary

wangliang@sysucc.org.cn

+86-20-87342462

Other Identifiers

PLPH

Identifier Type: -

Identifier Source: org_study_id