Clinical trial · Interventional
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
NCT02623959CI-TRIAL-00039928terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in combination with saline (the current standard of care) versus IPC in combination with doxycycline as treatment for pleural effusions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Malignant Pleural Effusions | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxycycline | Drug | — | UNRESOLVED |
| Fentanyl (IV) | Drug | — | UNRESOLVED |
| Fentanyl Patch | Drug | — | UNRESOLVED |
| Phone Calls | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indwelling Pleural Catheter (IPC) + Saline
- description
- Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status.
- interventionNames
- Behavioral: Questionnaires
- Drug: Fentanyl Patch
- Drug: Fentanyl (IV)
- Other: Saline
- Behavioral: Phone Calls
- type
- ACTIVE_COMPARATOR
- label
- Indwelling Pleural Catheter (IPC) + Doxycycline
- description
- Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Outpatients with MPE undergoing IPC placement 2. Age 18 or older 3. Sufficient mental capacity to answer SF-6D and Borg score questions. Exclusion Criteria: 1. Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) 2. Inability or unwillingness to give informed consent 3. Inability to perform phone call and clinical follow-up at MDACC 4. Previous intrapleural therapy for MPE on the same side 5. Chylous effusions associated with malignant disease 6. ECOG of 4 and life expectancy \</= 2 weeks 7. Doxycycline allergy 8. Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)
References
Publications (0)
Data not yet available
No reference posted for this study.