Breast Cancer Clinical Trial
Official title:
Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
NCT number | NCT04042298 |
Other study ID # | Pro9646 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 25, 2019 |
Est. completion date | June 2022 |
Verified date | March 2022 |
Source | Kansas State University |
Contact | Carl J Ade, PhD |
Phone | 785-532-1127 |
cade[@]ksu.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - (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 |
Country | Name | City | State |
---|---|---|---|
United States | Lafene Health Center | Manhattan | Kansas |
Lead Sponsor | Collaborator |
---|---|
Kansas State University |
United States,
Luwaert RJ, Descamps O, Majois F, Chaudron JM, Beauduin M. Coronary artery spasm induced by 5-fluorouracil. Eur Heart J. 1991 Mar;12(3):468-70. — View Citation
Polk A, Vistisen K, Vaage-Nilsen M, Nielsen DL. A systematic review of the pathophysiology of 5-fluorouracil-induced cardiotoxicity. BMC Pharmacol Toxicol. 2014 Sep 4;15:47. doi: 10.1186/2050-6511-15-47. Review. — View Citation
Sara JD, Kaur J, Khodadadi R, Rehman M, Lobo R, Chakrabarti S, Herrmann J, Lerman A, Grothey A. 5-fluorouracil and cardiotoxicity: a review. Ther Adv Med Oncol. 2018 Jun 18;10:1758835918780140. doi: 10.1177/1758835918780140. eCollection 2018. Review. — View Citation
Südhoff T, Enderle MD, Pahlke M, Petz C, Teschendorf C, Graeven U, Schmiegel W. 5-Fluorouracil induces arterial vasocontractions. Ann Oncol. 2004 Apr;15(4):661-4. — View Citation
Sutterfield SL, Caldwell JT, Post HK, Lovoy GM, Banister HR, Ade CJ. Lower cutaneous microvascular reactivity in adult cancer patients receiving chemotherapy. J Appl Physiol (1985). 2018 Oct 1;125(4):1141-1149. doi: 10.1152/japplphysiol.00394.2018. Epub 2018 Aug 9. — View Citation
Taniyama Y, Griendling KK. Reactive oxygen species in the vasculature: molecular and cellular mechanisms. Hypertension. 2003 Dec;42(6):1075-81. Epub 2003 Oct 27. Review. — View Citation
Yeh ET, Bickford CL. Cardiovascular complications of cancer therapy: incidence, pathogenesis, diagnosis, and management. J Am Coll Cardiol. 2009 Jun 16;53(24):2231-47. doi: 10.1016/j.jacc.2009.02.050. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cutaneous (skin) blood flow (%) following administration of vasoactive substances | Measured once in each group following administration of vasodilatory (Acetylcholine) and vasoconstrictive (Norepinepherine or Phenylephrine) substances. | 1 day | |
Primary | Brachial artery flow mediated dilation (FMD) | Measured once in each group | 1 day | |
Secondary | Arterial blood pressure | Systolic, diastolic, and mean arterial pressure will be measured continuously over the course of the visit for each group. | 1 day |
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