Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
研究概览
简要总结
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
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
- 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
- time to achieve significant pain relief
- side-effect profile?
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/> 4
排除标准
- •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
研究组 & 干预措施
fentanyl
active pain treatment with fentanyl patch
干预措施: fentanyl (Drug)
methadone
active pain treatment with methadone
干预措施: methadone (Drug)
结局指标
主要结局
significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%)
时间窗: 9 weeks
次要结局
- side-effect profile(9 weeks)
- time to achieve significant pain relief(9 weeks)