The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME-1)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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. |
- An average pain score over 72 hours post pleurodesis for malignant pleural effusion [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Presence of chronic chest pain on the side of the pleurodesis [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Presence of chronic chest pain on the side of the pleurodesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
- Histologically proven pleural malignancy OR
- Typical features of pleural malignancy seen on direct vision during thoracoscopy OR
- Pleural effusion in the context of histologically proven cancer elsewhere
- Expected survival more than 1 month
- Written informed consent
Exclusion Criteria:
- Age < 18 years
- Primary lymphoma or small cell lung carcinoma
- Patients who are pregnant or lactating
- Inability to give informed consent
- History of GI bleeding or of untreated peptic ulceration
- Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen
- Hypercapnic respiratory failure
- Known intravenous drug abuse
- Severe renal or liver disease
- Known bleeding diathesis
- Warfarin therapy
- Current or recent (within 2 weeks) corticosteroid steroid therapy
Contacts and Locations| United States, California | |
| UC Davis Medical Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Maya Juarez, CCRP 916-734-3643 maya.juarez@ucdmc.ucdavis.edu | |
| Principal Investigator: Ken Yoneda, MD | |
| Principal Investigator: | RJO Davies, Dr. | Oxford Pleural Unit, Churchill Hospital, Oxford, England |
More Information
No publications provided
| Responsible Party: | Ken Yoneda, MD, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00896285 History of Changes |
| Other Study ID Numbers: | 200816478 |
| Study First Received: | May 7, 2009 |
| Last Updated: | May 8, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Pleural malignancy pleural effusion pleurodesis |
chest tube cancer cancer pain management |
Additional relevant MeSH terms:
|
Analgesics Analgesics, Non-Narcotic Pleural Effusion Pleural Effusion, Malignant Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Anti-Inflammatory Agents, Non-Steroidal Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013