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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02347878
• Other study ID #: PLPH
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 21, 2015
• Last updated: January 26, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Sun Yat-sen University
• Contact: Liang Wang, doctor
• Phone: +86-20-87342462
• Email: wangliang[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Headache
• Leukemia
• Lymphoma

Intervention

Drug:
• Aprepitant
use aprepitant 1 hour before lumbar puncture and intrathecal treatment

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of any grade post-lumbar-puncture headache		date from the day of lumbar puncture to 2 weeks after lumbar puncture	No
Secondary	incidence of grade 3/4 post-lumbar-puncture headache		date from the day of lumbar puncture to 2 weeks after lumbar puncture	No