Skip to main content
Clinical Trials/NCT07317583
NCT07317583CompletedNot Applicable

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

Istanbul University - Cerrahpasa1 site in 1 country40 target enrollmentStarted: April 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Physical Restrictions Score (Visual Analog Scale)

Study Overview

Brief 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).

Detailed Description

Continuous infusion of 5-Fluorouracil (5-FU) via portable pumps is a common treatment modality for colorectal cancer, offering clinical benefits such as stable plasma drug levels and improved tolerability. However, patients often experience physical discomfort, restricted mobility, sleep disturbances, anxiety, and aesthetic concerns related to the infusion pump. Technical issues such as unstable connections and medication flow interruptions may further compromise treatment safety.

To address these challenges, this study introduces a newly designed supportive corset aimed at stabilizing the infusion pump and serum set during continuous 5-FU therapy. The corset is designed to enhance comfort, reduce movement-related anxiety, and improve sleep quality and overall treatment experience. This feasibility trial enrolled 40 patients diagnosed with colorectal cancer from an outpatient chemotherapy unit in Türkiye. Participants were randomized into two groups: the intervention group received the corset in addition to standard care, while the control group received standard care only.

Data were collected at baseline and after four weeks using the Visual Analog Scale (VAS) for infusion-related experiences and the EORTC QLQ-C30 for quality of life. The primary outcomes include changes in physical restrictions, insomnia, anxiety during movement, aesthetic concerns, and overall quality of life. Secondary outcomes include patient satisfaction with the corset. The study was approved by the Clinical Research Ethics Committee (Approval No: 2023-19-09) and conducted in accordance with ethical standards. Findings will inform the feasibility and potential integration of supportive physical devices into cancer care protocols.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Masking Description

This study is open-label; no masking was applied. Both participants and researchers were aware of group assignments because the intervention involved the use of a visible supportive corset during continuous 5-FU infusion therapy.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with colorectal cancer
  • Currently receiving chemotherapy
  • Having received at least one cycle of 5-FU therapy via continuous infusion
  • Volunteering to participate in the study
  • Aged 18 years or older

Exclusion Criteria

  • Diagnosis of brain cancer (excluded due to potential impact on cognitive function and reliability of self-reported data)
  • Presence of bone metastases
  • Pregnancy and/or lactation
  • Communication barriers
  • Physician-diagnosed mental illness
  • Inability to speak or understand Turkish

Arms & Interventions

Standard of Care + Supportive Corset

Experimental

Participants receive standard care plus a specially designed supportive corset during continuous 5-FU infusion.

Intervention: Supportive Corset (Device)

Standard of Care

Other

Participants receive routine care without any additional intervention.

Intervention: Standard care (Other)

Outcomes

Primary Outcomes

Physical Restrictions Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Insomnia Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Anxiety During Movement Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Skin Contact Discomfort Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Medication Flow Issues Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Aesthetic Concerns Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Nausea Score (Visual Analog Scale)

Time Frame: 4 weeks

Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

Secondary Outcomes

  • Quality of Life Score (EORTC QLQ-C30)(4 weeks)

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

EZGI BILMIC

Nurse Specialist

Istanbul University - Cerrahpasa

Study Sites (1)

Loading locations...

Similar Trials