NCT03465774 Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
| NCT ID | NCT03465774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Pleural Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 208 participants |
| Start Date | 2018-03-08 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 208 participants in total. It began in 2018-03-08 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.
Eligibility Criteria
Inclusion Criteria: * Outpatients with MPE undergoing IPC placement * Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions * Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter Exclusion Criteria: * Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) * Inability or unwillingness to give informed consent * Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC) * Pregnancy * Previous intrapleural therapy for MPE on the same side * Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =\< 2 weeks * Doxycycline allergy * Extensive loculations or hydropneumothorax or other contraindication to pleurodesis * Chylous effusions associated with malignant disease
Contact & Investigator
David Ost
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03465774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03465774 currently recruiting?
Yes, NCT03465774 is actively recruiting participants. Contact the research team at dost@mdanderson.org for enrollment information.
Where is the NCT03465774 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03465774 clinical trial?
NCT03465774 is sponsored by M.D. Anderson Cancer Center. The principal investigator is David Ost at M.D. Anderson Cancer Center. The trial plans to enroll 208 participants.