LeukemiaPhase 4NCT02347878
Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
A Phase 4 study testing Aprepitant in people with Leukemia and Lymphoma, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- With CNS involvement of disease
- With headache before lumbar puncture
- Needs lumbar puncture more than once a week
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Liang Wang, Doctor, +86-20-87342462, wangliang@sysucc.org.cn
About this study
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.
Read the 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.
- Being tested
- Aprepitant
- Keywords
- leukemia, lymphoma, lumbar puncture, intrathecal treatment, post-lumbar puncture headache
- Medical subject headings
- Leukemia, Lymphoma, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
use aprepitant 1 hour before lumbar puncture and intrathecal treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment. Receives: Drug: Aprepitant |
| control arm | No intervention | this arm will received nothing 1 hour before lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of any grade post-lumbar-puncture headache
Measured: 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
Measured: date from the day of lumbar puncture to 2 weeks after lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Wang, Sun Yat-sen University
- Investigators
- Liang Wang, DOCTOR, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347878
- Sponsor's protocol ID
- PLPH
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
- ClinicalTrials.gov ID
- NCT02347878
- Acronym / sponsor ID
- PLPH
- Keywords
- leukemia, lymphoma, lumbar puncture, intrathecal treatment, post-lumbar puncture headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Aprepitantthis treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment. |
| control arm | No intervention | –this arm will received nothing 1 hour before lumbar puncture |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- With CNS involvement of disease
- With headache before lumbar puncture
- Needs lumbar puncture more than once a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: Emenduse aprepitant 1 hour before lumbar puncture and intrathecal treatment | Drug | treatment arm |
Primary outcome
incidence of any grade post-lumbar-puncture headache
Time frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
1 secondary outcome
incidence of grade 3/4 post-lumbar-puncture headache
Time frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Wang, DOCTOR principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant in people with Leukemia and Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Wang, doctor (+86-20-87342462, wangliang@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of any grade post-lumbar-puncture headache (time frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.