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

NCT02347878 | Unknown Phase 4

• 1 other identifier: PLPH
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Lymphoma

Keywords

leukemia; lymphoma; lumbar puncture; intrathecal treatment; post-lumbar puncture headache

Outcome Measures

Primary Outcomes (1)

• incidence of any grade post-lumbar-puncture headache

  date from the day of lumbar puncture to 2 weeks after lumbar puncture

Secondary Outcomes (1)

• incidence of grade 3/4 post-lumbar-puncture headache

  date from the day of lumbar puncture to 2 weeks after lumbar puncture

Study Arms (2)

treatment arm

EXPERIMENTAL

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

Drug: Aprepitant

control arm

NO INTERVENTION

this arm will received nothing 1 hour before lumbar puncture

Interventions

Aprepitant DRUG

use aprepitant 1 hour before lumbar puncture and intrathecal treatment

Also known as: Emend

treatment arm

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• With CNS involvement of disease
• With headache before lumbar puncture
• Needs lumbar puncture more than once a week

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Post-Dural Puncture Headache

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Liang Wang, DOCTOR

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, doctor

CONTACT

+86-20-87342462; wangliang@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

CN (1)