CancerPhase 3Off-labelNCT00740571
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
A Phase 3 study testing amitriptyline and pregabalin in people with Cancer and Neuralgia, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- amitriptyline and pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2008to Dec 2010
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
VUMC
Amsterdam, North Holland, 1007MB
Roberto Perez, PhD, +31204440029, rsgm.perez@vumc.nl
Roberto Perez, PhD
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3000CA
Carin vd Rijt, MD, PhD, +31104391906, c.vanderrijt@erasmusmc.nl
Carin vd Rijt, MD, PhD
About this study
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
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.
Read more
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).
- Being tested
- amitriptyline, pregabalin
- Keywords
- neuralgia, off-label, cancer
- Medical subject headings
- Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amitriptylineDrug
Also called tryptizol
strategy in which the patient starts with amitriptyline, during 8 weeks
pregabalinDrug
Also called lyrica
Strategy in which patient starts with pregabalin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Strategy in which patient starts with amitriptyline Receives: Drug: amitriptyline |
| 2 | Active comparator | Strategy in which patient starts with pregabalin Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Measured: 8 weeks
Secondary outcomes (1)
EQ-5D, McGill, EORTC-C30, HADS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University of Amsterdam
- Investigators
- Kris Vissers, MD PhD FIPP, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740571
- Sponsor's protocol ID
- 80-82310-98-8612
- Acronym
- Off-label
- Status last verified
- Feb 2009
- First submitted
- 22 Aug 2008
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740571
- Acronym / sponsor ID
- Off-label / 80-82310-98-8612
- Keywords
- neuralgia, off-label, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, University of Amsterdam
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Aug 2008 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: amitriptylineStrategy in which patient starts with amitriptyline |
| 2 | Active comparator | Drug: pregabalinStrategy in which patient starts with pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18+
- Incurable cancer
- Life expectancy three months or longer
- NRS ≥ 4
- Neuropathic pain
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| amitriptylineAlso: tryptizolstrategy in which the patient starts with amitriptyline, during 8 weeks | Drug | 1 |
| pregabalinAlso: lyricaStrategy in which patient starts with pregabalin | Drug | 2 |
Primary outcome
VAS score
Time frame: 8 weeks
1 secondary outcome
EQ-5D, McGill, EORTC-C30, HADS
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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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.
Kris Vissers, MD PhD FIPP study director
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amitriptyline and pregabalin in people with Cancer and Neuralgia, run by Radboud University Medical Center at 2 sites in Netherlands.
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 8 inclusion and 9 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 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yvonne Engels, PhD (+31243616583, y.engels@anes.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 8 weeks). 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 5 Feb 2009.