Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 4
- 主要终点
- Numeric Rating Scale (NRS) at week 16
研究概览
简要总结
Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain.
详细描述
Radiotherapy for cancer is associated with peripheral neuropathies, especially with brachial plexus neuropathy and trigeminal neuralgia, which included painful sensation that are described as burning, aching, spasm, or tingling. Though there is some recommendation about neuropathic pain, there is no definite drug which is recommended for radiotherapy-related neuropathic pain.
Pregabalin, a central nervous system(CNS)-active compound, is an analog of the neurotransmitter gamma-aminobutyric acid. It has been proved an effective treatment for diabetic peripheral neuropathy and postherpetic neuralgia in previous clinical trials. This study plans to evaluate the efficacy of pregabalin versus placebo for relieving radiotherapy-related peripheral neuropathic pain, and assessed its safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must have received radiation therapy for histologically confirmed head and neck cancer.
- •Clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points).
- •Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire by two neurology specialists.
- •The mean duration of pain is more than 4 weeks.
- •Fertile women who are willing to take contraception during the trial.
- •Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.0 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; Hb >/=9.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain.
- •Evidence of secondary neuropathic pain other than radiation.
- •Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment.
- •Ongoing treatment for neuropathic pain.
- •History of anaphylactic response to pregabalin.
- •Evidence of sever systematic diseases.
研究组 & 干预措施
Pregabalin
Arm I:At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
干预措施: Pregabalin (Drug)
Placebo
Arm II:At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) at week 16
时间窗: week 16
The primary efficacy measure is the reduction of NRS from baseline to week 16.
次要结局
- Brief Pain Inventory (BPI)(week 16)
- Patient Global Impression of Change (PGIC)(week 16)
- the Profile of Mood States-Short Form (POMS-SF)(week 16)
- the World Health Organization Quality of Life-BREF (WHOQOL-BREF)(week 16)
- Clinical Global Impression of Change (CGIC)(week 16)
研究者
Yamei Tang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University