Skip to main content
OpenTrials
Completed

NCT Number: NCT01317589

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%

Other names: Durogesic

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%

Other names: Symoron

Primary outcomes

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

    Time frame: 9 weeks

Secondary outcomes

  1. time to achieve significant pain relief

    Time frame: 9 weeks

  2. side-effect profile

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: 310111-4

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2011
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.