The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME-1)
|ClinicalTrials.gov Identifier: NCT00896285|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : July 20, 2015
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.
The investigators hope to find the best way to prevent pain during pleurodesis.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusion Pleural Effusion||Other: Large bore chest drain + NSAID based analgesic regimen Other: Small bore chest drain + NSAID based analgesic regimen Other: Large bore chest drain + opiate based analgesic regimen Other: Small bore chest drain + opiate based analgesic regimen||Not Applicable|
Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. Talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. This procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. Reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure.
This trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. It will also address whether either of these influences success rate of pleurodesis.
We hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. We hope to find the best way of preventing pain during this procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Active Comparator: 1||
Other: Large bore chest drain + NSAID based analgesic regimen
Chest tube greater than 14 French size and ibuprofen.
|Active Comparator: 2||
Other: Small bore chest drain + NSAID based analgesic regimen
Chest tube less than or equal to 14 French size and ibuprofen.
|Active Comparator: 3||
Other: Large bore chest drain + opiate based analgesic regimen
Chest tube greater than 14 French size and morphine.
|Active Comparator: 4||
Other: Small bore chest drain + opiate based analgesic regimen
Chest tube less than or equal to 14 French size and morphine.
- An average pain score over 72 hours post pleurodesis for malignant pleural effusion [ Time Frame: 72 hours ]
- Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion) [ Time Frame: 3 months ]
- Presence of chronic chest pain on the side of the pleurodesis [ Time Frame: 6 weeks ]
- Presence of chronic chest pain on the side of the pleurodesis [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896285
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||RJO Davies, Dr.||Oxford Pleural Unit, Churchill Hospital, Oxford, England|