Colorectal CancerRCTNCT07317583
Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer
A study testing Supportive Corset in people with Colorectal Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Supportive Corset
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, Bakirköy, 34500
About this study
Official title: Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer: A Feasibility Study
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).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Supportive Corset, Standard care
- Keywords
- Colorectal Cancer, 5-Fluorouracil (5-FU)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CorsetDevice
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 careOther
Routine care provided during continuous 5-FU infusion without any additional supportive device.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + Supportive Corset | Experimental | Participants receive standard care plus a specially designed supportive corset during continuous 5-FU infusion. Receives: Device: Supportive Corset |
| Standard of Care | Other | Participants receive routine care without any additional intervention. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Restrictions Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Insomnia Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Anxiety During Movement Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Skin Contact Discomfort Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Medication Flow Issues Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Aesthetic Concerns Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Nausea Score (Visual Analog Scale)
Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.
Measured: 4 weeks
Secondary outcomes (1)
Quality of Life Score (EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 questionnaire (30 items). Functional scales: higher scores = better functioning; symptom scales: higher scores = worse symptoms. Range: 0-100.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start10 Apr 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel-group, randomized controlled feasibility trial designed to evaluate the effectiveness and usability of a newly developed supportive corset for patients receiving continuous 5-Fluorouracil (5-FU) infusion therapy. Forty colorectal cancer patients were randomly assigned to two groups: an intervention group using the corset in addition to standard care and a control group receiving standard care only. The intervention lasted four weeks, and outcomes were assessed at baseline and post-intervention using the Visual Analog Scale (VAS) for infusion-related experiences and the EORTC QLQ-C30 for quality of life.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EZGI BILMIC, Istanbul University - Cerrahpasa
- Investigators
- Gülcan Bağçivan, PHD, Study director, University of Massachusetts Dartmouth, North Dartmouth, United States, Department of Adult Nursing, College of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317583
- Sponsor's protocol ID
- 2023-19-09
- Acronym
- RCT
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07317583
- Acronym / sponsor ID
- RCT / 2023-19-09
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, 5-Fluorouracil (5-FU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a parallel-group, randomized controlled feasibility trial designed to evaluate the effectiveness and usability of a newly developed supportive corset for patients receiving continuous 5-Fluorouracil (5-FU) infusion therapy. Forty colorectal cancer patients were randomly assigned to two groups: an intervention group using the corset in addition to standard care and a control group receiving standard care only. The intervention lasted four weeks, and outcomes were assessed at baseline and post-intervention using the Visual Analog Scale (VAS) for infusion-related experiences and the EORTC QLQ-C30 for quality of life.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Supportive Corset | Experimental | Device: Supportive CorsetParticipants receive standard care plus a specially designed supportive corset during continuous 5-FU infusion. |
| Standard of Care | Other | Other: Standard careParticipants receive routine care without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CorsetA 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. | Device | Standard of Care + Supportive Corset |
| Standard careRoutine care provided during continuous 5-FU infusion without any additional supportive device. | Other | Standard of Care |
Primary outcome
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.
1 secondary outcome
Quality of Life Score (EORTC QLQ-C30)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
RecruitingPhase 1/2
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülcan Bağçivan, PHD study director
University of Massachusetts Dartmouth, North Dartmouth, United States, Department of Adult Nursing, College of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Corset in people with Colorectal Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Restrictions Score (Visual Analog Scale) (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.