Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
18 Years
N/A
Both
Pain, Cancer of Head and Neck
Trial Information
Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
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%
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
Outcome Time Frame:
9 weeks
Safety Issue:
No
Principal Investigator
Maarten van Kleef, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Maastricht University Medical Center
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
METC 11-2-007
NCT ID:
NCT01317589
Start Date:
May 2011
Completion Date:
November 2013
Related Keywords:
- Pain
- Cancer of Head and Neck
- Pain
- Cancer of Head and Neck
- methadone
- Fentanyl
- Head and Neck Neoplasms
- Headache
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