Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion

NCT04792970 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00107258
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the experiences of subjects who drain malignant (cancerous) pleural effusions (fluid) from around their lung(s) in a more frequent manner using a talc instilled via tunneled pleural catheter combined with daily drainage and those subjects who drain this fluid in a daily standard manner.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Undergoing Accelerated Pleurodesis

  Up to 90 Days

Secondary Outcomes (4)

• Dyspnea as Measured by Questionnaire

  Baseline, 30 days, 90 Days

• Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline

  Baseline

• Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days

  30 days

• Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days

  90 days

Study Arms (2)

Talc instilled via tunneled pleural catheter combined with standard daily drainage

ACTIVE COMPARATOR

This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.

Drug: Talc

Standard daily drainage

NO INTERVENTION

This arm consists of eligible participants who are randomized to control group and would not receive any intervention.

Interventions

Talc DRUG

All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.

Talc instilled via tunneled pleural catheter combined with standard daily drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 18 years of age, inclusive.
• Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:
• There is histocytological confirmation of pleural malignancy
• The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.
• Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
• Subject has sufficient pleural fluid to allow safe insertion of an IPC.
• Subject has negative pregnancy test if appropriate.
• Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member, or paid healthcare professional).

You may not qualify if:

• Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, two separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after tunneled pleural catheter insertion. Significant trapped lung is deemed present if any 1 of the following criteria is met:
• A CXR shows hydropneumothorax other than small (\< 1 cm between chest wall and pleural line) apical pneumothoraces.
• A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
• A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).
• Subject has a Karnofsky score \<50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.
• Subject is pregnant, planning to become pregnant, or is lactating.
• Subject has a history of empyema.
• Subject has a history of chylothorax.
• Subject has an uncorrected coagulopathy.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Wahidi MM, Reddy C, Yarmus L, Feller-Kopman D, Musani A, Shepherd RW, Lee H, Bechara R, Lamb C, Shofer S, Mahmood K, Michaud G, Puchalski J, Rafeq S, Cattaneo SM, Mullon J, Leh S, Mayse M, Thomas SM, Peterson B, Light RW. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1050-1057. doi: 10.1164/rccm.201607-1404OC.

  PMID: 27898215 BACKGROUND

• Bhatnagar R, Keenan EK, Morley AJ, Kahan BC, Stanton AE, Haris M, Harrison RN, Mustafa RA, Bishop LJ, Ahmed L, West A, Holme J, Evison M, Munavvar M, Sivasothy P, Herre J, Cooper D, Roberts M, Guhan A, Hooper C, Walters J, Saba TS, Chakrabarti B, Gunatilake S, Psallidas I, Walker SP, Bibby AC, Smith S, Stadon LJ, Zahan-Evans NJ, Lee YCG, Harvey JE, Rahman NM, Miller RF, Maskell NA. Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion. N Engl J Med. 2018 Apr 5;378(14):1313-1322. doi: 10.1056/NEJMoa1716883.

  PMID: 29617585 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Talc

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Results Point of Contact

• Title: Scott Shofer
• Organization: Duke University Medical Center

scott.shofer@duke.edu

(919) 668-2402

Study Officials

• Scott Shofer

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: March 18, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)