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The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00896285
First received: May 7, 2009
Last updated: May 8, 2009
Last verified: May 2009

May 7, 2009
May 8, 2009
April 2009
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00896285 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The First Therapeutic Intervention in Malignant Pleural Effusion Trial
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Malignant Pleural Effusion
  • Pleural Effusion
  • Other: Large bore chest drain + NSAID based analgesic regimen
    Chest tube greater than 14 French size and ibuprofen.
  • Other: Small bore chest drain + NSAID based analgesic regimen
    Chest tube less than or equal to 14 French size and ibuprofen.
  • Other: Large bore chest drain + opiate based analgesic regimen
    Chest tube greater than 14 French size and morphine.
  • Other: Small bore chest drain + opiate based analgesic regimen
    Chest tube less than or equal to 14 French size and morphine.
  • Active Comparator: 1
    Intervention: Other: Large bore chest drain + NSAID based analgesic regimen
  • Active Comparator: 2
    Intervention: Other: Small bore chest drain + NSAID based analgesic regimen
  • Active Comparator: 3
    Intervention: Other: Large bore chest drain + opiate based analgesic regimen
  • Active Comparator: 4
    Intervention: Other: Small bore chest drain + opiate based analgesic regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00896285
200816478
Yes
Ken Yoneda, MD, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: RJO Davies, Dr. Oxford Pleural Unit, Churchill Hospital, Oxford, England
University of California, Davis
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP