PainPhase 4310111-4NCT01317589
Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective?
A Phase 4 study testing fentanyl and methadone in people with Pain and Cancer of Head and Neck, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background of the study: Treatment of Pain in Head-and-Neck Cancer Patients: is methadone more effective than fentanyl? Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one third of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Cancer of Head and Neck
- What is being tested?
- fentanyl and methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/> 4
Who cannot join
- age under 18
- not being able to read or fill in the questionnaires
- recent operation (less than 7 days)
- women of childbearing potential not using contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
Background of the study:
Treatment of Pain in Head-and-Neck Cancer Patients:
Read more
is methadone more effective than fentanyl?
Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one third of the patients. In patients with head-and-neck cancer neuropathic pain is far more prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is complex and available treatment modalities achieve (partial) pain relief in only 40-60% of patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in patients with cancer.
Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor antagonist qualities have been described. Many small studies and case-reports describe the successful rotation from different strong opioids to methadone. There are no studies that selected patients with (predominantly) neuropathic pain to be treated with methadone, whereas this group of patients is expected to profit from the NMDAR-antagonist properties of methadone.
Objective of the study:
This randomised controlled trial (RCT) aims to investigate whether addition of a NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of predominantly neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief and time to achieve significant pain relief.
Study design:
Open label randomised controlled trial
Study population:
opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of ≥ 4, age =/> 18 years
Intervention Treatment with methadone or fentanyl patch
Primary study parameters/outcome of the study:
Is methadone more effective than fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
- pain interference
Secondary study parameters/outcome of the study:
Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- time to achieve significant pain relief
- side-effect profile?
Read the detailed description
Study design The duration of the study will be 9 weeks. Patients will visit the outpatient clinic 5 times. Patients of MAASTRO clinic will be seen directly before or after the radiation therapy. No extra visits will be necessary.
T= -1: - informed consent
- sort of pain (DN4)
- randomisation
T = 0 - questionnaire 1: demographic variables, disease specific variables, BPI, side effect questions, HADS, QoL
- explain and provide the pain sheet
- start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
- breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
T=1 - questionnaire 2: BPI, side effect questions, global perceived effect
1 week - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
T=2 - questionnaire 2: BPI, side effect questions, global perceived effect 3 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T=3 - questionnaire 2: BPI, side effect questions, global perceived effect 5 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T = 4 - questionnaire 3: BPI, side effect questions, global perceived effect, QoL
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
- Conditions
- Pain, Cancer of Head and Neck
- Being tested
- fentanyl, methadone
- Keywords
- Pain, Cancer of Head and Neck, methadone, Fentanyl
- Medical subject headings
- Pain, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Also called Durogesic
T = 0
- start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
- breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
T=1
1 week
- if necessary increase dose strong opioid with 50%
T=2 3 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T=3 5 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T = 4 9 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
methadoneDrug
Also called Symoron
T = 0
- start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
- breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
T=1
1 week
- if necessary increase dose strong opioid with 50%
T=2 3 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T=3 5 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T = 4 9 weeks
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | active pain treatment with fentanyl patch Receives: Drug: fentanyl |
| methadone | Experimental | active pain treatment with methadone Receives: Drug: methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
Measured: 9 weeks
Secondary outcomes (2)
time to achieve significant pain relief
Measured: 9 weeks
side-effect profile
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Maastricht 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten van Kleef, MD, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317589
- Sponsor's protocol ID
- METC 11-2-007
- Acronym
- 310111-4
- Status last verified
- Jul 2015
- First submitted
- 16 Feb 2011
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
- ClinicalTrials.gov ID
- NCT01317589
- Acronym / sponsor ID
- 310111-4 / METC 11-2-007
- Conditions
- Pain, Cancer of Head and Neck
- Keywords
- Pain, Cancer of Head and Neck, methadone, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Mar 2011 (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.
Background of the study:
Treatment of Pain in Head-and-Neck Cancer Patients:
is methadone more effective than fentanyl?
Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one third of the patients. In patients with head-and-neck cancer neuropathic pain is far more prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is complex and available treatment modalities achieve (partial) pain relief in only 40-60% of patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in patients with cancer.
Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor antagonist qualities have been described. Many small studies and case-reports describe the successful rotation from different strong opioids to methadone. There are no studies that selected patients with (predominantly) neuropathic pain to be treated with methadone, whereas this group of patients is expected to profit from the NMDAR-antagonist properties of methadone.
Objective of the study:
This randomised controlled trial (RCT) aims to investigate whether addition of a NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of predominantly neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief and time to achieve significant pain relief.
Study design:
Open label randomised controlled trial
Study population:
opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of ≥ 4, age =/> 18 years
Intervention Treatment with methadone or fentanyl patch
Primary study parameters/outcome of the study:
Is methadone more effective than fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
- pain interference
Secondary study parameters/outcome of the study:
Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- time to achieve significant pain relief
- side-effect profile?
Detailed description
Study design The duration of the study will be 9 weeks. Patients will visit the outpatient clinic 5 times. Patients of MAASTRO clinic will be seen directly before or after the radiation therapy. No extra visits will be necessary.
T= -1: - informed consent
- sort of pain (DN4)
- randomisation
T = 0 - questionnaire 1: demographic variables, disease specific variables, BPI, side effect questions, HADS, QoL
- explain and provide the pain sheet
- start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
- breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
T=1 - questionnaire 2: BPI, side effect questions, global perceived effect
1 week - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
T=2 - questionnaire 2: BPI, side effect questions, global perceived effect 3 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T=3 - questionnaire 2: BPI, side effect questions, global perceived effect 5 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T = 4 - questionnaire 3: BPI, side effect questions, global perceived effect, QoL
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: fentanylactive pain treatment with fentanyl patch |
| methadone | Experimental | Drug: methadoneactive pain treatment with methadone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/> 4
Key exclusion criteria (4 listed)
- age under 18
- not being able to read or fill in the questionnaires
- recent operation (less than 7 days)
- women of childbearing potential not using contraception
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 |
|---|---|---|
| fentanylAlso: DurogesicT = 0 * start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur * breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day T=1 1 week * if necessary increase dose strong opioid with 50% T=2 3 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% T=3 5 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% T = 4 9 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% | Drug | fentanyl |
| methadoneAlso: SymoronT = 0 * start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur * breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day T=1 1 week * if necessary increase dose strong opioid with 50% T=2 3 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% T=3 5 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% T = 4 9 weeks * if necessary increase dose strong opioid with 50% * if necessary decrease dose strong opioid with 30% | Drug | methadone |
Primary outcome
significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
Time frame: 9 weeks
2 secondary outcomes
time to achieve significant pain relief
Time frame: 9 weeks
side-effect profile
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 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.
Maarten van Kleef, MD, PhD study chair
Maastricht University Medical 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 fentanyl and methadone in people with Pain and Cancer of Head and Neck, run by Maastricht University Medical Center at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 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 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) (time frame: 9 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 16 Jul 2015.