Clinical trial · Interventional
Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer
Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard care | Other | — | UNRESOLVED |
| Supportive Corset | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard of Care + Supportive Corset
- description
- Participants receive standard care plus a specially designed supportive corset during continuous 5-FU infusion.
- interventionNames
- Device: Supportive Corset
- type
- OTHER
- label
- Standard of Care
- description
- Participants receive routine care without any additional intervention.
- interventionNames
- Other: Standard care
Primary outcomes (7)
- measure
- Physical Restrictions Score (Visual Analog Scale)
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available