Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
Completed
Conditions studied: Gastrointestinal Cancer, Head and Neck Cancer, Breast Cancer, Chemotherapy Effect, 5-Fluorouracil Toxicity
In brief
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.
Key facts
- Study ID
- NCT04042298
- Run by
- Kansas State University
- People needed
- 62
- Starts
- 2019-06-25
- Expected to finish
- 2023-06-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Give voluntary consent to participate in the study
- (Group 1) Current cancer treatment includes 5-FU
- (Group 2) Current cancer treatment does not include 5-FU
- (Group 3) Cancer survivor previously treated with 5-FU but has not received cancer treatment in the year proceeding enrollment.
- (Group 4) Age, sex, and health matched (excluding cancer) control for Group 1
You may not qualify if…
- (Groups 1, 2, and 4) Have received cancer treatment outside of the past year
- Not met above criteria
- Pregnant, breastfeeding, or planning to become pregnant
- Unable to provide informed consent
Where it is running
- Lafene Health Center — Manhattan, Kansas, United States
Full record on ClinicalTrials.gov
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