MedTrace Logo

Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer

NCT07317583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-05

No results posted yet for this study

Summary

This feasibility randomized controlled trial aims to evaluate the effectiveness and usability of a newly designed supportive corset for patients receiving continuous 5-Fluorouracil (5-FU) infusion therapy. The corset is intended to stabilize the infusion pump and serum set, reduce physical and psychological discomfort, and improve overall quality of life. Forty colorectal cancer patients were randomized into two groups: an intervention group using the corset and a control group receiving standard care. Outcomes include infusion-related experiences (measured by Visual Analog Scale) and quality of life (assessed by EORTC QLQ-C30).

Conditions

Interventions

DEVICE

Supportive Corset

A specially designed supportive corset developed to stabilize the 5-FU infusion pump and serum set during continuous infusion therapy. It includes a body-wrapping belt, adjustable shoulder strap aligned with the port catheter, and a fluid-proof pouch for carrying the infusion pump. The corset aims to enhance comfort, reduce physical and psychological distress, and improve overall treatment experience.

OTHER

Standard care

Routine care provided during continuous 5-FU infusion without any additional supportive device.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Gülcan Bağçivan, PHD · University of Massachusetts Dartmouth, North Dartmouth, United States, Department of Adult Nursing, College of Nursing and Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2024-12-10
Completion
2024-12-10

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317583 on ClinicalTrials.gov