Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer (Off-label)
Primary Purpose
Cancer, Neuralgia
Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
amitriptyline
pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring neuralgia, off-label, cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18+
- Incurable cancer
- Life expectancy three months or longer
- NRS ≥ 4
- Neuropathic pain
- Adequate renal function with cockroft ≥ 60 ml/min
- Signed informed consent
- Expected adequacy of follow up
Exclusion Criteria:
- Previous use of TAD or AED for neuropathic pain within 30 days prior to screening
- Unstable regime of analgetica for 1 week prior to screening
- Use of cannabis
- Radiotherapy aimed at the source of the neuropathic pain 2 weeks before screening
- Chemotherapy with known neurotoxic effect (taxanes, thalidomide, vinca alkaloids, cytarabine,fluoropyrimidines, oxaliplatin) 2 weeks before screening
- Unstable regime of corticosteroids for 1 week prior to screening
- Pregnancy
- Any condition preventing the intake or absorption of oral drugs
- Participation in any other studies involving investigational products within the 30 days prior to screening
Sites / Locations
- VUMCRecruiting
- Erasmus MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Strategy in which patient starts with amitriptyline
Strategy in which patient starts with pregabalin
Outcomes
Primary Outcome Measures
VAS score
Secondary Outcome Measures
EQ-5D, McGill, EORTC-C30, HADS
Full Information
NCT ID
NCT00740571
First Posted
August 22, 2008
Last Updated
February 4, 2009
Sponsor
Radboud University Medical Center
Collaborators
Erasmus Medical Center, University of Amsterdam
1. Study Identification
Unique Protocol Identification Number
NCT00740571
Brief Title
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
Acronym
Off-label
Official Title
A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Erasmus Medical Center, University of Amsterdam
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label medication is not allowed anymore unless a standard or protocol exists. No clinical trials for this patient group have been published before.
Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.
Study design: An open label, randomised non-inferiority trial Study population: Incurable cancer patients with neuropathic pain Intervention: When a patient decides to take part in the study, he will be allocated randomly to one of the two study groups. A minimisation algorithm will be used, that balances for the cause of neuropathic pain (tumour related versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up procedure. Patients will be followed during 8 weeks.
Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill questionnaire, strategy success, costs per strategy, side effects, quality of life and concomitant analgesic drugs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are hardly any risks for the patients. The drugs in both arms already are usual care for the target population. If there is no or a too small effect, the drug of the other arm will be added, which strategy also is already usual care. All other medication, except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times during the study period. The patient had to fill in a pain diary daily (5 min), cost diary and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30 monthly (20 min).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Neuralgia
Keywords
neuralgia, off-label, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Strategy in which patient starts with amitriptyline
Arm Title
2
Arm Type
Active Comparator
Arm Description
Strategy in which patient starts with pregabalin
Intervention Type
Drug
Intervention Name(s)
amitriptyline
Other Intervention Name(s)
tryptizol
Intervention Description
strategy in which the patient starts with amitriptyline, during 8 weeks
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
lyrica
Intervention Description
Strategy in which patient starts with pregabalin
Primary Outcome Measure Information:
Title
VAS score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
EQ-5D, McGill, EORTC-C30, HADS
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18+
Incurable cancer
Life expectancy three months or longer
NRS ≥ 4
Neuropathic pain
Adequate renal function with cockroft ≥ 60 ml/min
Signed informed consent
Expected adequacy of follow up
Exclusion Criteria:
Previous use of TAD or AED for neuropathic pain within 30 days prior to screening
Unstable regime of analgetica for 1 week prior to screening
Use of cannabis
Radiotherapy aimed at the source of the neuropathic pain 2 weeks before screening
Chemotherapy with known neurotoxic effect (taxanes, thalidomide, vinca alkaloids, cytarabine,fluoropyrimidines, oxaliplatin) 2 weeks before screening
Unstable regime of corticosteroids for 1 week prior to screening
Pregnancy
Any condition preventing the intake or absorption of oral drugs
Participation in any other studies involving investigational products within the 30 days prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Engels, PhD
Phone
+31243616583
Email
y.engels@anes.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Annelies Schalkwijk, MSc
Phone
+31243666254
Email
a.schalkwijk@anes.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Vissers, MD PhD FIPP
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
VUMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1007MB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Perez, PhD
Phone
+31204440029
Email
rsgm.perez@vumc.nl
First Name & Middle Initial & Last Name & Degree
Roberto Perez, PhD
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3000CA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin vd Rijt, MD, PhD
Phone
+31104391906
Email
c.vanderrijt@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Carin vd Rijt, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
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