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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Lymphoma; Leukemia

Treatments: Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT02347878

PLPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

treatment arm

Experimental group

Description:

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

Treatment:

Drug: Aprepitant

control arm

No Intervention group

Description:

this arm will received nothing 1 hour before lumbar puncture