Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective? (310111-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01317589
First received: February 16, 2011
Last updated: July 15, 2015
Last verified: July 2015
History of Changes
  Purpose

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?

Condition Intervention Phase
Pain
Cancer of Head and Neck
 Drug: fentanyl
Drug: methadone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to achieve significant pain relief [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • side-effect profile [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
Enrollment: 134
Study Start Date: May 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fentanyl
active pain treatment with fentanyl patch
 Drug: fentanyl

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 Name: Durogesic
Experimental: methadone
active pain treatment with methadone
 Drug: methadone

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 Name: Symoron

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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317589

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: Maarten van Kleef, MD, PhD Maastricht University Medical Center
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01317589     History of Changes
Other Study ID Numbers: METC 11-2-007 
Study First Received: February 16, 2011
Last Updated: July 15, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Pain
Cancer of Head and Neck
methadone
Fentanyl

Additional relevant MeSH terms:
Head and Neck Neoplasms
Headache
Neoplasms by Site
Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Methadone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 28, 2016