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CTRI Number  CTRI/2025/04/085011 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 30/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Treatments for Managing Lung Fluid in Cancer Patients 
Scientific Title of Study   Efficacy of pleurodesis using Doxycycline 500mg, Doxycycline 1000mg and 4g Talc slurry in management of Malignant Pleural Effusion – A pilot study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yogalakshmi 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department of pulmonary medicine, JIPMER, Pondicherry - 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  6383977818  
Fax    
Email  yogiv27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Saka Vinod Kumar 
Designation  Professor(senior scale) 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department of pulmonary medicine, JIPMER, Pondicherry - 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9442108095  
Fax    
Email  vinoddayamani@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Saka Vinod Kumar 
Designation  Professor (senior scale) 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department of pulmonary medicine, JIPMER, Pondicherry - 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9442108095  
Fax    
Email  vinoddayamani@hotmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Gorimedu, pondicherry - 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Gorimedu, pondicherry - 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogalakshmi  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  ward 27, first floor, old block, IPD ,Department of pulmonary medicine
Pondicherry
PONDICHERRY 		 06383977818

yogiv27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - Interventional Studies, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J910||Malignant pleural effusion,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Doxycycline 1000mg  Tab. DOXYCYCLINE 1000MG made into a 50ml solution using 0.9%NaCl – intrapleural instillation through intercostal drainage tube.- One time procedure which lasts for 15-30 minutes 
Intervention  Doxycycline 500mg  Tab. DOXYCYCLINE 500MG made into a 50ml solution using 0.9%NaCl – intrapleural instillation through intercostal drainage tube- One time procedure which lasts for 15-30 minutes 
Intervention  Steritalc  STERITALC – 4gm made into a slurry with 50mL of 0.9%NaCl – intrapleural instillation through intercostal drainage tube.- One time procedure which lasts for 15-30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed malignant pleural effusion cases 
 
ExclusionCriteria 
Details  1. Previously attempted and failed pleurodesis
2. Contraindications for pleurodesis
3. Contraindication for ICD tube placement
4. History of allergy to any tetracycline derivatives or talc.
5. Previous history of ARDS
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the success rates and complications of high-dose doxycycline 1000mg and talc slurry 4gm in comparison to a standard dose of doxycycline 500mg for pleurodesis in cases of malignant pleural effusion  At the end of one week 
 
Secondary Outcome  
Outcome  TimePoints 
To assess status of pleurodesis   at the end of one month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [yogiv27@gmail.com].

  6. For how long will this data be available start date provided 30-06-2026 and end date provided 01-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Malignant pleural effusion (MPE) is a common complication of advanced malignancy with a poor prognosis.Progressive dyspnea is the most common symptom  followed by cough and chest pain that affect the quality of life.Current local managements include thoracentesis, pleurodesis, chest tube drainage, indwelling pleural catheter drainage, pleurectomy, and pleuro peritoneal shunting.Pleurodesis is a procedure aiming at the adhesion of the visceral and parietal pleura that prevents the accumulation of MPE and subsequently improves symptoms. Pleurodesis can be completed by chemical sclerosants or by physical abrasion of pleural surfaces during thoracoscopy or thoracotomy. In this study we are going to compare the efficacy of pleurodesis using 3 different sclerosants - doxycycline 500mg, doxycyline 1000mg and talc slurry 4gm. 
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