The First Therapeutic Intervention in Malignant Pleural Effusion Trial

Pleural Effusion Clinical Trial

— TIME-1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896285
• Other study ID #: 200816478
• Status: Completed
• Phase: N/A
• First received: May 7, 2009
• Last updated: July 16, 2015
• Start date: April 2009
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Expected survival more than 1 month

3. Written informed consent

Exclusion Criteria:

1. Age < 18 years

2. Primary lymphoma or small cell lung carcinoma

3. Patients who are pregnant or lactating

4. Inability to give informed consent

5. History of GI bleeding or of untreated peptic ulceration

6. Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen

7. Hypercapnic respiratory failure

8. Known intravenous drug abuse

9. Severe renal or liver disease

10. Known bleeding diathesis

11. Warfarin therapy

12. Current or recent (within 2 weeks) corticosteroid steroid therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Other:
• Large bore chest drain + NSAID based analgesic regimen
Chest tube greater than 14 French size and ibuprofen.
• Small bore chest drain + NSAID based analgesic regimen
Chest tube less than or equal to 14 French size and ibuprofen.
• Large bore chest drain + opiate based analgesic regimen
Chest tube greater than 14 French size and morphine.
• Small bore chest drain + opiate based analgesic regimen
Chest tube less than or equal to 14 French size and morphine.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An average pain score over 72 hours post pleurodesis for malignant pleural effusion		72 hours	No
Primary	Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)		3 months	No
Secondary	Presence of chronic chest pain on the side of the pleurodesis		6 weeks	No
Secondary	Presence of chronic chest pain on the side of the pleurodesis		6 months	No