A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The Primary Outcomes of Interest Will be Time to Catheter Removal.
研究概览
简要总结
The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in combination with saline (the current standard of care) versus IPC in combination with doxycycline as treatment for pleural effusions.
详细描述
IPC Placement and Placement Follow-Up:
Before the IPC is inserted, you will complete 2 questionnaires about your quality of life and any symptoms you may have. It should take no more than 15-20 minutes to complete. You will also have a chest x-ray and you will rate your pain on a scale of 1-10. These tests are all part of your standard of care and can be explained to you in more detail by your doctor. You will be required to sign a separate consent form in order to have the IPC placed. Your doctor will give you detailed instructions about the IPC placement procedure, including its risks.
After the IPC is placed, the doctor will give you a prescription for a fentanyl patch to help control pain. The study staff will tell you how and when to wear the fentanyl patch and about any side effects that are associated with fentanyl.
About 5 days (+/- 2 days) after the IPC has been placed, you will have a clinic visit where you will be checked up on as part of your standard of care. It is important that you wear your fentanyl patch in the morning before this visit. At this clinic visit, the results of a previously performed chest x-ray will be reviewed, you will be asked to rate your pain on a scale of 1-10, and you will be asked how much fluid has drained from your catheter.
Based on the results of the above Day 5 check-up, if you are found to be ineligible to receive the study drug, the fentanyl patch will be taken off and you will be followed as part of your usual care. However, you will still considered to be on study and you will be followed the same as a participant who receives the study drug.
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, Investigator)
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
- •Outpatients with MPE undergoing IPC placement
- •Age 18 or older
- •Sufficient mental capacity to answer SF-6D and Borg score questions.
排除标准
- •Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
- •Inability or unwillingness to give informed consent
- •Inability to perform phone call and clinical follow-up at MDACC
- •Previous intrapleural therapy for MPE on the same side
- •Chylous effusions associated with malignant disease
- •ECOG of 4 and life expectancy </= 2 weeks
- •Doxycycline allergy
- •Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)
研究组 & 干预措施
Indwelling Pleural Catheter (IPC) + Saline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
干预措施: Saline (Other)
Indwelling Pleural Catheter (IPC) + Saline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
干预措施: Questionnaires (Behavioral)
Indwelling Pleural Catheter (IPC) + Saline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
干预措施: Fentanyl Patch (Drug)
Indwelling Pleural Catheter (IPC) + Saline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
干预措施: Fentanyl (IV) (Drug)
Indwelling Pleural Catheter (IPC) + Saline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status.
干预措施: Phone Calls (Behavioral)
Indwelling Pleural Catheter (IPC) + Doxycycline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status
干预措施: Questionnaires (Behavioral)
Indwelling Pleural Catheter (IPC) + Doxycycline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status
干预措施: Fentanyl Patch (Drug)
Indwelling Pleural Catheter (IPC) + Doxycycline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status
干预措施: Fentanyl (IV) (Drug)
Indwelling Pleural Catheter (IPC) + Doxycycline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status
干预措施: Doxycycline (Drug)
Indwelling Pleural Catheter (IPC) + Doxycycline
Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.
After the IPC is removed, participant is called one time each month by study staff to check on their status
干预措施: Phone Calls (Behavioral)
结局指标
主要结局
The Primary Outcomes of Interest Will be Time to Catheter Removal.
时间窗: 1 month
This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed the cause for removal will be documented. For the analysis causes will include removal due to decreased drainage (i.e. as per plan) as well as removal due to complications (e.g. infection, empyema, and refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication).
次要结局
未报告次要终点