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

Primary Purpose

Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aprepitant
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia focused on measuring leukemia, lymphoma, lumbar puncture, intrathecal treatment, post-lumbar puncture headache

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment arm

control arm

Arm Description

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

this arm will received nothing 1 hour before lumbar puncture

Outcomes

Primary Outcome Measures

incidence of any grade post-lumbar-puncture headache

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2015
Last Updated
January 26, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02347878
Brief Title
Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
Official Title
Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
leukemia, lymphoma, lumbar puncture, intrathecal treatment, post-lumbar puncture headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.
Arm Title
control arm
Arm Type
No Intervention
Arm Description
this arm will received nothing 1 hour before lumbar puncture
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
use aprepitant 1 hour before lumbar puncture and intrathecal treatment
Primary Outcome Measure Information:
Title
incidence of any grade post-lumbar-puncture headache
Time Frame
date from the day of lumbar puncture to 2 weeks after lumbar puncture
Secondary Outcome Measure Information:
Title
incidence of grade 3/4 post-lumbar-puncture headache
Time Frame
date from the day of lumbar puncture to 2 weeks after lumbar puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Wang, doctor
Phone
+86-20-87342462
Email
wangliang@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Wang, DOCTOR
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, Doctor
Phone
+86-20-87342462
Email
wangliang@sysucc.org.cn

12. IPD Sharing Statement

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

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