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Enrolling By Invitation
NCT07697170
Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi
Conditions: Colon Cancer, Cancer Pancreas
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Institut Català d'Oncologia
Location: Sandra Cabrera Jaime Badalona Barcelona
Summary
This randomized controlled clinical trial evaluates the safety equivalence between weekly and biweekly dressing changes for peripherally inserted central catheters (PICC) in oncology patients receiving outpatient chemotherapy.
The study will assess vascular access functionality, skin integrity including Medical Adhesive-Related Skin Injury (MARSI), and the incidence of catheter-related complications.
A total of 150 adult patients with colon or pancreas cancer receiving chemotherapy and requiring PICC insertion will be randomized into two groups: weekly dressing changes (control group) or biweekly dressing changes every 14 days (intervention group).
Participants will be followed during chemotherapy treatment for a minimum of six cycles and up to twelve sessions. Outcomes include catheter-related complications, patient satisfaction with vascular access care, and quality of life measured using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire).
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of colon or pancreas cancer
* Indication for PICC insertion for chemotherapy administration
* Chemotherapy regimen including FOLFOX6, FOLFOX4, FOLFIRI, or mFOLFIRI
* Ability to understand the study procedures
* Signed written informed consent
Exclusion Criteria:
* Catheter-related infection within the previous 30 days
* Known allergy to adhesive dressings
* Raynaud syndrome
* Skin jaundice or cyanosis at baseline
Source: ClinicalTrials.gov (NCT07697170). StuddyBuddy aggregates publicly available trial information.