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Completed

NCT Number: NCT07317583

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa

Istanbul, Bakirköy, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Corset

Device

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.

Standard care

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. Quality of Life Score (EORTC QLQ-C30)

    Time frame: 4 weeks

    Assessed using EORTC QLQ-C30 questionnaire (30 items). Functional scales: higher scores = better functioning; symptom scales: higher scores = worse symptoms. Range: 0-100.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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