Comparing indwelling pleural catheters with or without doxycycline for treating fluid build-up in the lungs
A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
This study is testing if adding doxycycline to the use of indwelling pleural catheters can help people with fluid build-up in the lungs feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03465774 on ClinicalTrials.gov |
What this trial studies
This study aims to gather preliminary data on the effectiveness of indwelling pleural catheters (IPCs) alone versus IPCs combined with doxycycline for treating malignant pleural effusions (MPE). Patients will be assigned to one of two groups: one receiving IPC placement followed by doxycycline administration, and the other receiving only IPC placement. The study will monitor patients for treatment outcomes and quality of life over a follow-up period of up to one year. The goal is to determine if the addition of doxycycline can reduce treatment duration.
Who should consider this trial
Good fit: Ideal candidates include outpatients with malignant pleural effusions who are undergoing IPC placement and can provide informed consent.
Not a fit: Patients with benign pleural diseases or those who have previously received intrapleural therapy on the same side may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and quicker treatment options for patients suffering from malignant pleural effusions.
How similar studies have performed: While the use of IPCs is common, the specific combination with doxycycline for this purpose is less established, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Ost — M.D. Anderson Cancer Center
- Study coordinator: David Ost
- Email: dost@mdanderson.org
- Phone: 713-792-6238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.