RecruitingPhase 1

OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

Denmark20 participantsStarted 2023-09-15

Plain-language summary

This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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.
✕. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
✕. have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis

What they're measuring

Medical adverse events

Timeframe: 30 days from PITAC directed treatment

Surgical complications

Timeframe: 30 days from PITAC directed treatment

Trial details

NCT IDNCT06421610

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Pernille Schjødt Hansen, Student

+45 65411857 pernille.schjodt.hansen@rsyd.dk

View on ClinicalTrials.gov More Malignant Pleural Effusion trials