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NCT04042298 · ClinicalTrials.gov registry record
Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
A clinical trial, sponsored by Kansas State University.
- Completed
- Registry status
- 62
- Enrollment target
NCT04042298: Completed study, sponsored by Kansas State University.
NCT04042298 is a clinical trial that has completed, run by Kansas State University. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042298 has completed, sponsored by Kansas State University.
- COMPLETED
- Registry status
- 62 participants
- Enrollment target
Study Summary
The primary aim of this study is to investigate potential differences in vascular function between patients receiving 5-Fluorouracil (5-FU) chemotherapy, patients receiving chemotherapies other than 5-FU, cancer survivors who were treated with 5-FU, and an age and sex matched control. 5-FU is the third most commonly administered chemotherapeutic agent and its use is associated with the second most occurrences of cardiotoxicity. Despite the known cardiotoxic effects of 5-FU, it's effects on the human vasculature are not well understood. To achieve the goals of this project Laser Doppler flowmetry (LDF) will be used to assess blood flow within the skin microcirculation of the forearm in cancer patients who have received 5-Fluoruracil within the past 30 days (Experimental Group), cancer patients receiving radiotherapy and/or chemotherapy other than 5-Fluorouracil, and an age and sex matched control (Control Group). LDF utilizes a small (\~3 cm) non-invasive sensor placed on the skin. The sensor shines light into the skin, and upon contact with red blood cells (RBCs), the light is reflected and scattered. This information is used to evaluate microvascular blood flow and has previously been used in clinical populations.
Primary Outcome
Measured once in each group following administration of vasodilatory (Acetylcholine) and vasoconstrictive (Norepinepherine or Phenylephrine) substances.
Interventions
- OTHER Arterial blood pressure
- OTHER Skin microcirculatory blood flow
- OTHER Brachial artery blood flow
- OTHER Venous blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2023-06-01 |
What the finished NCT04042298 record still lists
NCT04042298 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Arterial blood pressure is the first listed.
NCT04042298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04042298 about?
NCT04042298 is a clinical study titled "Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy". The primary aim of this study is to investigate potential differences in vascular function between patients receiving 5-Fluorouracil (5-FU) chemotherapy, patients receiving chemotherapies other than 5-FU, cancer survivors who were treated with 5-FU, and an age and sex matched control. 5-FU is the th...
What is the current status of trial NCT04042298?
This trial is currently completed. The enrollment target is 62 participants. The study started on 2019-06-25. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04042298?
The interventions under investigation include: Arterial blood pressure (OTHER), Skin microcirculatory blood flow (OTHER), Brachial artery blood flow (OTHER), Venous blood draw (OTHER).
Who is sponsoring clinical trial NCT04042298?
This trial is sponsored by Kansas State University, which has 22 total clinical trials registered on ClinicalTrials.gov.
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