Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- concentration of tramadol consumption
研究概览
简要总结
Cancer pain is one of the most common and problematic symptoms. Opioids are typically the most common drugs used in the treatment of cancer pain,they are limited due to their side effects.
Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors, and is effective in the treatment of moderate to severe pain.
Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in such patients.
Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and peripheral pain modulation .
详细描述
Cancer pain is one of the most common and problematic symptoms.uncontrolled pain affect quality of life and daily activities .Cancer pain has two main categories nociceptive and neuropathic pain,Cancer pain is often a combination of nociceptive and neuropathic pain.
A framework for managing pain often starts with the World Health Organization (WHO) Analgesic Ladder, step 1 use non opioid analgesics, step 2 weak opioids, step 3 strong opioids, step 4 interventions non pharmacological, adjuvants can be added to any step .
Opioids are typically the most common drugs used in the treatment of cancer pain. They work by binding to μ-opioid receptors within the central nervous system, which are responsible for opioid mediated analgesia, respiratory depression, sedation, physiological dependence, and tolerance, they are limited due to their side effects as nausea, constipation, sedation, and confusion, prolonged use of opioids may lead to development of tolerance, abnormal hypersensitivity to pain.
Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors, and is effective in the treatment of moderate to severe pain. It has been also shown to inhibit reuptake of serotonin and norepinephrine, which synergistically enhances its weak opioid mechanism of action.
This may explain the reduced incidences of abuse, respiratory depression and other adverse effects of traditional opioids in patients on long-term tramadol therapy.it is a useful drug in patients with cancer pain both with nociceptive and neuropathic pain .Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer pain
- •age from 20-70 years old.
- •not receiving any type of analgesia before (opioid naïve, no adjuvants).
排除标准
- •Difficult to be assessed for pain.
- •Any contraindication for duloxetine or tramadol.
研究组 & 干预措施
•tramadol and duloxetine
patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive duloxetine 30mg daily fixed dose in combination with tramadol. Investigators will follow up the patients for 3 months
干预措施: Duloxetine 30 mg (Drug)
•tramadol and duloxetine
patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive duloxetine 30mg daily fixed dose in combination with tramadol. Investigators will follow up the patients for 3 months
干预措施: Tramadol (Drug)
tramadol and placebo
patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive placebo drug once daily in combination with tramadol. Investigators will follow up the patients for 3 months
干预措施: Tramadol (Drug)
tramadol and placebo
patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive placebo drug once daily in combination with tramadol. Investigators will follow up the patients for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
concentration of tramadol consumption
时间窗: at one month
all participants(400 patients) will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks,according to changes in visual analogue scale for pain maximum dose will be 400mg daily, one group of participants(200 patients) will receive duloxetine 30mg daily fixed dose in combination with tramadol,decrease in concentration of tramadol consumption means better results,the other group(200 patients) will receive placebo drug once daily in combination with tramadol.
次要结局
- Depression scores by the Patient Health Questionnaire(at 1 month,2 month and 3 month)
- concentration of tramadol consumption(at 2 month and 3 month)
- Leeds Assessment of Neuropathic Symptoms and Signs Scale if neuropathic pain(at 1 month,2 month and 3 month)
- - change in pain with visual analogue scale(at 3,6,9 and 12 days , 2 weeks,1 month,2 month,3 month)
- type of pain that relieved better(at 1 month,2 month and 3 month)
- Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity)(at 1 month,2 month and 3 month)
- Anxiety scores by the Patient Health Questionnaire(at 1 month,2 month and 3 month)
- Flanagan Quality of Life Scale(at 1 month,2 month and 3 month)
- Side effects as nausea, vomiting, constipation, sedation, arrhythmia and hypertension(up to 3 month)