Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective?
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
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?