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Pain | Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective?

Pain research study

What is the primary objective of this study?

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?

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Cancer of Head and Neck

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:fentanylT = 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:methadoneT = 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

fentanylactive pain treatment with fentanyl patch

methadoneactive pain treatment with methadone

Study Status

Completed

Start Date: May 2011

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)

Secondary Outcome: time to achieve significant pain relief

Study sponsors, principal investigator, and references

Principal Investigator: Maarten van Kleef, MD, PhD

Lead Sponsor: Maastricht University Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01317589

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