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
  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.

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896285

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         
Sponsors and Collaborators
University of California, Davis
Investigators
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:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014