NCT02583282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

5.4 years

First QC Date

August 4, 2015

Last Update Submit

October 5, 2022

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (3)

  • Complete success

    long-term relief of symptoms related to the effusion, with absence of re-accumulation of fluid on chest radiograph at 30 days

    30 days

  • Partial success

    diminution of dyspnea related to the effusion, with only partial reaccumulation of fluid and no requirement for therapeutic thoracentesis

    30 days

  • Failed pleurodesis

    reaccumulation of pleural fluid requiring therapeutic thoracentesis, persistence of drainage output \>250mL/day requiring repeat procedure, lack of success requiring surgical intervention

    30 days

Secondary Outcomes (1)

  • Time to pleurodesis

    1 week

Study Arms (2)

Doxycycline

EXPERIMENTAL

Intrapleural doxycycline

Other: Doxycycline

Iodopovidine

ACTIVE COMPARATOR

Intrapleural iodopovidine

Other: Iodopovidine

Interventions

DoxycyclineOTHER

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.

Doxycycline
IodopovidineOTHER

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.

Iodopovidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

  • Damaraju V, Sehgal IS, Muthu V, Prasad KT, Dhooria S, Aggarwal AN, Agarwal R. Efficacy and safety of doxycycline versus iodopovidone for pleurodesis through an intercostal tube in malignant pleural effusions: a randomized trial. Support Care Cancer. 2023 Jul 10;31(8):454. doi: 10.1007/s00520-023-07932-y.

    PMID: 37428348DERIVED

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

August 4, 2015

First Posted

October 22, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations

IN(1)