Aerosol chemotherapy for patients with malignant pleural effusion
Implementation and Evaluation of Pressurized Intrathoracic Aerosol Chemotherapy (PITAC) for the Treatment of Patients With Malignant Pleural Effusion. A Danish Phase I Study (OPC5 Study)
PHASE1 · Odense University Hospital · NCT06421610
This study is testing a new way to deliver chemotherapy directly into the chest for patients with malignant pleural effusion to see if it’s safe and helps improve their quality of life.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy, doxorubicin |
| Locations | 1 site (Odense) |
| Trial ID | NCT06421610 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) for patients suffering from malignant pleural effusion (MPE). It involves administering aerosolized chemotherapy directly into the pleural cavity and monitoring patients for adverse events and surgical complications. The study will also assess quality of life, pain, and breathlessness through various questionnaires and visual analogue scales at multiple follow-up points. A total of 20 patients will undergo at least two PITAC procedures, with treatments spaced four weeks apart.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic malignant pleural effusion who have a verified malignancy and meet specific health criteria.
Not a fit: Patients with severe renal impairment, significant heart issues, or those allergic to the chemotherapy agents used may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with malignant pleural effusion.
How similar studies have performed: While this approach is innovative, similar aerosol chemotherapy methods have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic MPE visible with bedside ultrasound * Histologically or cytologically verified malignancy * Status CT-scan not older than four weeks * MPE requiring at least one drainage procedure * Drained ≥ 14 days before the first PITAC directed treatment * Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy * ECOG Performance status 0-2 * Life expectancy ≥ 3 months * Age ≥ 18 years * Danish-speaking and reading patients * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin * Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation) * Myocardial insufficiency, defined as NYHA class \> 2 * Impaired liver function defined as bilirubin ≥1.5 * Fertility, pregnancy and lactation: Female subjects will be considered of non-reproductive potential if they are either a, b or c: 1. postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening. 3. have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis * Any other condition or therapy, which in the investigator´s opinion may pose a risk to the patient or interfere with the study objects
Where this trial is running
Odense
- Odense PIPAC Center, Department of Surgery, Odense University Hospital — Odense, Denmark (RECRUITING)
Study contacts
- Study coordinator: Pernille Schjødt Hansen, Student
- Email: pernille.schjodt.hansen@rsyd.dk
- Phone: +45 65411857
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.
Conditions: Malignant Pleural Effusion, Pleural Neoplasms, Quality of Life, Chemotherapy Effect, Chemotherapeutic Toxicity, Pleural Carcinomatosis, Pleural Cavity Effusion