Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective? (310111-4)
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| ClinicalTrials.gov Identifier: NCT01317589 |
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Recruitment Status :
Completed
First Posted : March 17, 2011
Last Update Posted : July 16, 2015
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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?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Cancer of Head and Neck | Drug: fentanyl Drug: methadone | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 134 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl? |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: fentanyl
active pain treatment with fentanyl patch
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Drug: fentanyl
T = 0
T=1 1 week
T=2 3 weeks
T=3 5 weeks
T = 4 9 weeks
Other Name: Durogesic |
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Experimental: methadone
active pain treatment with methadone
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Drug: methadone
T = 0
T=1 1 week
T=2 3 weeks
T=3 5 weeks
T = 4 9 weeks
Other Name: Symoron |
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) [ Time Frame: 9 weeks ]
- time to achieve significant pain relief [ Time Frame: 9 weeks ]
- side-effect profile [ Time Frame: 9 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/> 4
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317589
| Netherlands | |
| University Hospital Maastricht | |
| Maastricht, Netherlands, 6202AZ | |
| Study Chair: | Maarten van Kleef, MD, PhD | Maastricht University Medical Center |
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01317589 History of Changes |
| Other Study ID Numbers: |
METC 11-2-007 |
| First Posted: | March 17, 2011 Key Record Dates |
| Last Update Posted: | July 16, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Maastricht University Medical Center:
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Pain Cancer of Head and Neck methadone Fentanyl |
Additional relevant MeSH terms:
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Head and Neck Neoplasms Headache Neoplasms by Site Neoplasms Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Fentanyl Methadone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics Antitussive Agents Respiratory System Agents |