Clinical trial NCT00896285: The First Therapeutic Intervention in Malignant Pleural Effusion Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Pleural Effusion
Pleural Effusion
Keywords: Pleural malignancy
pleural effusion
pleurodesis
chest tube
cancer
cancer pain management
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 criteria: 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

Primary outcomes:
measure: An average pain score over 72 hours post pleurodesis for malignant pleural effusion
timeFrame: 72 hours
measure: Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)
timeFrame: 3 months
Secondary outcomes:
measure: Presence of chronic chest pain on the side of the pleurodesis
timeFrame: 6 weeks
measure: Presence of chronic chest pain on the side of the pleurodesis
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Oxford Pleural Unit, Churchill Hospital, Oxford, England
name: RJO Davies, Dr.
role: PRINCIPAL_INVESTIGATOR
References: