A Pilot Study Aimed at Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in ESAS Pain Subscore
研究概览
简要总结
The aim of this clinical trial is to assess the effectiveness of intratracheal analgesia on pain intensity in cancer patients, from the start of treatment up to 3 months. It will also investigate the safety of this technique. The main questions it seeks to answer are as follows:
What is the impact on the use of opioid analgesics, and can this be measured? What is the quality of life? What is the quality of sleep, and can this be assessed? How does the patient's weight change? Is the patient satisfied? What is the patient's overall survival?
The researchers will assess the equivalent daily dose of morphine (mg/day) between enrolment and follow-up visits, as well as the number of patients requiring an escalation of analgesic treatment. Overall quality of life score measured using the ESAS questionnaire between enrolment and follow-up visits; satisfaction assessed using a numerical satisfaction scale (0-10); sleep quality assessed using the ISI questionnaire; and the tolerability and safety of the technique assessed by monitoring adverse events.
Eligible participants:
Following implantation of the intrathecal pump, participants will have scheduled consultations at day 30, then at 3, 6, 9 and 12 months, with questionnaires to be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged over 20 years
- •Patient with histologically confirmed pancreatic carcinoma
- •Chronic cancer-related pain that is inadequately controlled by standard treatment or for whom analgesics are contraindicated.
- •EMO < 120 mg/day Patients experiencing side effects: sedation, vomiting, constipation, or an allergy to morphine.
- •Signed informed consent
- •Participants affiliated with or eligible for a social security scheme
- •Agree to complete the various study questionnaires
排除标准
- •Patients under the age of
- •Contraindications to intratracheal analgesia
- •Acute respiratory infection
- •Uncontrolled coagulation disorder
- •Pregnancy or breastfeeding
- •Unable to comply with medical follow-up for the study.
- •Adults who are legally protected, under guardianship or under a conservatorship
研究组 & 干预措施
Intrathecal catheter implantable pump
Administration of the medicine via an intrathecal catheter connected to an implantable pump
干预措施: Intrathecal catheter connected to an implantable pump (Device)
Intrathecal catheter implantable pump
Administration of the medicine via an intrathecal catheter connected to an implantable pump
干预措施: Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections (Drug)
结局指标
主要结局
Change in ESAS Pain Subscore
时间窗: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in pain intensity score measured by the ESAS subscale from baseline to follow-up visits. Unit of Measure: Score on a scale (0 to 10)
Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore
时间窗: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in pain intensity score measured by the ESAS subscale from baseline to follow-up visits. Unit of Measure: Score on a scale (0 to 10) Scale Range (Minimum and Maximum Values): 0 to 10 Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).
次要结局
- Change in ESAS Overall Quality of Life Score(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Proportion of Patients Requiring Pain Treatment Escalation(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Change in Daily Morphine Equivalent Dose (MED)(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Change in Sleep Quality Score (ISI)(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Change in Body Weight(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Patient Satisfaction Score(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Incidence of Adverse Events Related to Intratracheal Analgesia(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Incidence of Serious Adverse Events (SAEs)(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Change in Edmonton Symptom Assessment System (ESAS) Overall Quality of Life Score(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Change in Sleep Quality Score Insomnia Severity Index (ISI)(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)
- Patient Satisfaction Clinical Global Impressions Scale (typically either CGI-Severity or CGI-Improvement)(Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months)