Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective?
Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer of Head and Neck
Intervention: fentanyl (Drug); methadone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Maastricht University Medical Center Official(s) and/or principal investigator(s): Maarten van Kleef, MD, PhD, Study Chair, Affiliation: Maastricht University Medical Center
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. 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
1. significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
2. 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
1. time to achieve significant pain relief
2. side-effect profile?
Clinical Details
Official title: Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
Secondary outcome: time to achieve significant pain reliefside-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%
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital Maastricht, Maastricht 6202AZ, Netherlands
Additional Information
Starting date: May 2011
Last updated: July 15, 2015
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