Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.
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
- 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
- •Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with oral/systemic opioids for at least 4 weeks, and are expected to remain on opioids for the entire duration of the study. More than one opioid rotation has to be done before defining pain refractoriness.
- •Intrathecal therapy is recommended because of inefficacy or intolerance to strong systemic opioid treatment. Inefficacy is defined as mean daily visual analogue scale (VAS) pain intensity score at rest of ≥ 50 mm. Intolerance is defined as the occurrence of (S)AEs (even with dosage less than 200 mg/day of oral morphine equivalents) which prevents a further increase in the opioid dosage to obtain pain relief.
- •Patients suitable for IDD and with the ability to comply with the medical protocol and visits.
- •Survival prognosis of ≥ 6 months.
排除标准
- •Patients with active, severe infection.
- •Patients with known brain metastases.
- •Patients with high risk of hemorrhaging.
- •Patients with respiratory depression (for use of morphine).
- •Patients with severe respiratory compromise; baseline oxygen SpO2 < 90%, chronic CO2 retention.
- •Patients with severe cardiac disease or risk of cardiotoxicity (for use of bupivacaine).
- •Patients with severe liver impairment or liver failure (for use of ropivacaine).
- •Patients with allergies for medication or IDD hardware.
- •Pregnant or lactating women.
- •Women who plan to become pregnant within 1 month after the study.
结局指标
主要结局
Health-related quality of life
时间窗: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Health-related quality of life will be evaluated with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
次要结局
- Perceived Injustice(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Patient comfort(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Survival(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Pain intensity(At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation)
- Perceived stress(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Anxiety(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Self-efficacy(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Caregiver burden(At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation)
- Health expenditure(monthly after treatment initiation until 12 months)
- Safety(Throughout the duration of the study, an average of 12 months.)
- Number of responders(at 1, 2, 4, 6, and 12 months post-treatment initiation)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel