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A Study to Compare the Efficacy and Safety of Intrapleural Doxycycline Versus Iodopovidone for Performing Pleurodesis in Malignant Pleural Effusion

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ClinicalTrials.gov Identifier: NCT02583282
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research

Brief Summary:
Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion. Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for the management of MPE. According to a recent survey, tetracycline or its derivative (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a previous study from the investigators' center, the investigators have demonstrated equal efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also, iodopovidone has been postulated to have anti-neoplastic effects and hence may help in reducing the drain output. Apart from these benefits iodopovidone is easily available and is cost effective. The investigators believe that iodopovidone will have better efficacy than doxycycline in inducing pleurodesis in malignant pleural effusion.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Other: Doxycycline Other: Iodopovidine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Study to Compare the Efficacy and Safety of Intrapleural Doxycycline Versus Iodopovidone for Performing Pleurodesis in Malignant Pleural Effusion
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Doxycycline
Intrapleural doxycycline
Other: Doxycycline
500 mg of doxycycline will be dissolved in 50 ml of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours.

Active Comparator: Iodopovidine
Intrapleural iodopovidine
Other: Iodopovidine
20 ml of 10% betadine (Microshield, Johnson and Johnson, Solan, India) will be dissolved in 80 mL of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours.




Primary Outcome Measures :
  1. Complete success [ Time Frame: 30 days ]
    long-term relief of symptoms related to the effusion, with absence of re-accumulation of fluid on chest radiograph at 30 days

  2. Partial success [ Time Frame: 30 days ]
    diminution of dyspnea related to the effusion, with only partial reaccumulation of fluid and no requirement for therapeutic thoracentesis

  3. Failed pleurodesis [ Time Frame: 30 days ]
    reaccumulation of pleural fluid requiring therapeutic thoracentesis, persistence of drainage output >250mL/day requiring repeat procedure, lack of success requiring surgical intervention


Secondary Outcome Measures :
  1. Time to pleurodesis [ Time Frame: 1 week ]
    interval between instillation of the agent and removal of the chest tube



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrent symptomatic malignant pleural effusion, with subjective improvement of dyspnea following thoracentesis

Exclusion Criteria:

  • history of any allergy to iodine or doxycycline
  • history of thyroid disorders
  • failure of lung expansion after insertion of intercostal tube (trapped lung)
  • presence of air leaks
  • advanced malignancy with limited predicted life expectancy (<30 days)
  • failure to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583282


Locations
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India
Bronchoscopy suite, PGIMER Recruiting
Chandigarh, India, 160012
Contact: Ritesh Agarwal, MD, DM    0172-2756825    riteshpgi@gmail.com   
Contact: Inderpaul S Sehgal, MD, DM    0172-2748215    ipdoc_2000@hotmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Ritesh Agarwal, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02583282     History of Changes
Other Study ID Numbers: INT/IEC/2015/232
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents