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

NCT01317589 | Completed Phase 4

• 1 other identifier: METC 11-2-007
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. 1.significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
2. 2.pain interference
3. 3.time to achieve significant pain relief
4. 4.side-effect profile?

Conditions

Pain; Cancer of Head and Neck

Keywords

Pain; Cancer of Head and Neck; methadone; Fentanyl

Outcome Measures

Primary Outcomes (1)

• significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)

  9 weeks

Secondary Outcomes (2)

• time to achieve significant pain relief

  9 weeks

• side-effect profile

  9 weeks

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

active pain treatment with fentanyl patch

Drug: fentanyl

methadone

EXPERIMENTAL

active pain treatment with methadone

Drug: methadone

Interventions

fentanyl DRUG

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%

Also known as: Durogesic

fentanyl

methadone DRUG

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%

Also known as: Symoron

methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/\> 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Pain; Head and Neck Neoplasms

Interventions

Fentanyl; Methadone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ketones; Organic Chemicals

Study Officials

• Maarten van Kleef, MD, PhD

  Maastricht University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: March 17, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

NL (1)