Gastrointestinal CancerNCT04042298
Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
An observational study of Gastrointestinal Cancer and Head and Neck Cancer, run by Kansas State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancer, Head and Neck Cancer, Breast Cancer
- What is being tested?
- Arterial blood pressure, Skin microcirculatory blood flow and Brachial artery blood flow
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 1 Jun 2023
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed cancer patients who have received (or are scheduled to receive) 5-FU chemotherapy within the past 30 days (n=26) will enter the study soon after initiation of treatment. Newly diagnosed cancer patients receiving cancer treatment other than 5-FU (n=26; chemotherapy, radiotherapy, etc.) will enter into the study soon after initiation of treatment. Cancer survivors (n=26) who have previously received 5-FU but not within the year proceeding enrollment will be entered into the study. Age, sex, and health (n=26; excluding cancer) matched controls will be included in the study.
Who may be able to join
- 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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Although cancer continues to be one of the leading causes of death each year, advancements in cancer treatments and detection have improved patient prognosis across a large number of cancer types. This trend of improved survival rates has made apparent the significant risk of chemotherapy on the cardiovascular system in such a way that cardiotoxicity has become a prime concern in cancer survivors. Indeed, cardiotoxic events have been related to numerous chemotherapy types, including the commonly used 5-Fluorouracil (5-FU). 5-FU is the third most commonly administered form of chemotherapy used in the treatment of solid malignancies. Despite undeniable effectiveness in treating cancer, administration of 5-FU is associated with the second highest incidence of cardiotoxicity out of all chemotherapeutic agents.
Such cardiotoxic manifestations typically appear in the form of chest pain, angina during rest and/or exertion, and acute coronary syndromes, however, other events such as arrythmias, myocarditis, pericarditis, heart failure, or even death have been reported following 5-FU administration. While multiple mechanisms are believed to lead to 5-FU cardiotoxicity, the effects 5-FU has on the vasculature seem to be of particular importance. Initial findings suggest these drugs have a direct toxic effect on the vascular endothelium and smooth muscle, likely through increases in reactive oxygen species (ROS). ROS are known to adversely affect endothelium independent and dependent factors which influence vascular tone. Along with increased ROS, decreases in antioxidant capacity following 5-FU therapy lead to increased vasospasms and altered vasodilator/constrictor responses. Indeed, both coronary artery vasospasms and brachial artery vasoconstriction have been found to occur in some groups directly after injection of 5-FU.
Although the primary signaling pathways for 5-FU induced cardiotoxicity are well documented, many of these studies have been conducted in animal models. Previous work has demonstrated substantial vascular dysfunction in current cancer patients undergoing adjuvant systematic chemotherapy when compared to healthy controls, however, alike investigations specifically focused on vascular dysfunction in patients receiving 5-FU have yet to be conducted. To investigate such mechanisms, microvascular reactivity will be measured with laser Doppler flowmetry combined with iontophoresis of acetylcholine in cancer patients currently undergoing treatment with 5-Fluorouracil, patients receiving chemotherapy treatments other than 5-Fluorouracil, cancer survivors previously treated with 5-Fluorouracil, and age and sex matched controls.
- Conditions
- Gastrointestinal Cancer, Head and Neck Cancer, Breast Cancer, Chemotherapy Effect, 5-Fluorouracil Toxicity
- Being tested
- Arterial blood pressure, Skin microcirculatory blood flow, Brachial artery blood flow, Venous blood draw
- Medical subject headings
- Gastrointestinal Neoplasms, Head and Neck Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood pressureOther
Measured using an automated non-invasive finger cuff that obtains beat-by-beat blood pressure measurements via finger photoplesmography. Briefly, changes in artery diameter are detected through infrared light in the finger cuff. (Finometer Pro, FMS, The Netherlands).
Skin microcirculatory blood flowOther
Assessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine and norepinepherine or phenylepherine via iontophoresis.
Brachial artery blood flowOther
A GE Ultrasound System will be used to non-invasively assess brachial artery blood flow prior to and following a standard flow mediated dilation protocol.
Venous blood drawOther
A venous blood sample from the antecubital vein or a vein in the back of the hand will be taken via venipuncure by a nurse or a certified phlebotomist at the beginning of the experimental visit. These blood samples will be analyzed for the presence of reactive oxygen species and inflammatory markers.
| Study group | Role | What they receive |
|---|---|---|
| 5-FU Chemotherapy (Experimental) | Comprised of newly diagnosed cancer patients 21 years or older who have received 5-FU chemotherapy within the past 30 days or are scheduled to receive 5-FU chemotherapy. Receives: Other: Arterial blood pressure; Other: Skin microcirculatory blood flow; Other: Brachial artery blood flow; Other: Venous blood draw | |
| Non-5-FU Chemotherapy (Sub-Control) | Comprised of newly diagnosed cancer patients 21 years or older who have received chemotherapy other than 5-FU within the past 30 days or are scheduled to receive chemotherapy other than 5-FU. Receives: Other: Arterial blood pressure; Other: Skin microcirculatory blood flow; Other: Brachial artery blood flow; Other: Venous blood draw | |
| Age/Sex matched Control (Control) | Age, biological sex, and prior health history (excluding cancer diagnosis) matched control for cancer patients Receives: Other: Arterial blood pressure; Other: Skin microcirculatory blood flow; Other: Brachial artery blood flow; Other: Venous blood draw | |
| 5-FU Chemotherapy Cancer Survivor (Survivor) | Cancer survivors who have not received cancer therapy during the past year but previously received 5-Fluorouracil chemotherapy. Receives: Other: Arterial blood pressure; Other: Skin microcirculatory blood flow; Other: Brachial artery blood flow; Other: Venous blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Brachial artery flow mediated dilation (FMD)
Measured once in each group
Measured: 1 day
Secondary outcomes (1)
Arterial blood pressure
Systolic, diastolic, and mean arterial pressure will be measured continuously over the course of the visit for each group.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start25 Jun 2019
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Ade, M.S., Ph.D., Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042298
- Sponsor's protocol ID
- Pro9646
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2019
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19520246Sara 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.
PubMed 29977352Taniyama Y, Griendling KK. Reactive oxygen species in the vasculature: molecular and cellular mechanisms. Hypertension. 2003 Dec;42(6):1075-81. doi: 10.1161/01.HYP.0000100443.09293.4F. Epub 2003 Oct 27.
PubMed 14581295Polk 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.
PubMed 25186061Luwaert 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. doi: 10.1093/oxfordjournals.eurheartj.a059919.
PubMed 2040332Sudhoff 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. doi: 10.1093/annonc/mdh150.
PubMed 15033676Sutterfield 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.
PubMed 30091663
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy
- ClinicalTrials.gov ID
- NCT04042298
- Acronym / sponsor ID
- Pro9646
- Conditions
- Gastrointestinal Cancer, Head and Neck Cancer, Breast Cancer, Chemotherapy Effect, 5-Fluorouracil Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Aug 2019 (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.
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.
Detailed description
Although cancer continues to be one of the leading causes of death each year, advancements in cancer treatments and detection have improved patient prognosis across a large number of cancer types. This trend of improved survival rates has made apparent the significant risk of chemotherapy on the cardiovascular system in such a way that cardiotoxicity has become a prime concern in cancer survivors. Indeed, cardiotoxic events have been related to numerous chemotherapy types, including the commonly used 5-Fluorouracil (5-FU). 5-FU is the third most commonly administered form of chemotherapy used in the treatment of solid malignancies. Despite undeniable effectiveness in treating cancer, administration of 5-FU is associated with the second highest incidence of cardiotoxicity out of all chemotherapeutic agents.
Such cardiotoxic manifestations typically appear in the form of chest pain, angina during rest and/or exertion, and acute coronary syndromes, however, other events such as arrythmias, myocarditis, pericarditis, heart failure, or even death have been reported following 5-FU administration. While multiple mechanisms are believed to lead to 5-FU cardiotoxicity, the effects 5-FU has on the vasculature seem to be of particular importance. Initial findings suggest these drugs have a direct toxic effect on the vascular endothelium and smooth muscle, likely through increases in reactive oxygen species (ROS). ROS are known to adversely affect endothelium independent and dependent factors which influence vascular tone. Along with increased ROS, decreases in antioxidant capacity following 5-FU therapy lead to increased vasospasms and altered vasodilator/constrictor responses. Indeed, both coronary artery vasospasms and brachial artery vasoconstriction have been found to occur in some groups directly after injection of 5-FU.
Although the primary signaling pathways for 5-FU induced cardiotoxicity are well documented, many of these studies have been conducted in animal models. Previous work has demonstrated substantial vascular dysfunction in current cancer patients undergoing adjuvant systematic chemotherapy when compared to healthy controls, however, alike investigations specifically focused on vascular dysfunction in patients receiving 5-FU have yet to be conducted. To investigate such mechanisms, microvascular reactivity will be measured with laser Doppler flowmetry combined with iontophoresis of acetylcholine in cancer patients currently undergoing treatment with 5-Fluorouracil, patients receiving chemotherapy treatments other than 5-Fluorouracil, cancer survivors previously treated with 5-Fluorouracil, and age and sex matched controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5-FU Chemotherapy (Experimental) | – | Other: Arterial blood pressure, Other: Skin microcirculatory blood flow, Other: Brachial artery blood flow, Other: Venous blood drawComprised of newly diagnosed cancer patients 21 years or older who have received 5-FU chemotherapy within the past 30 days or are scheduled to receive 5-FU chemotherapy. |
| Non-5-FU Chemotherapy (Sub-Control) | – | Other: Arterial blood pressure, Other: Skin microcirculatory blood flow, Other: Brachial artery blood flow, Other: Venous blood drawComprised of newly diagnosed cancer patients 21 years or older who have received chemotherapy other than 5-FU within the past 30 days or are scheduled to receive chemotherapy other than 5-FU. |
| Age/Sex matched Control (Control) | – | Other: Arterial blood pressure, Other: Skin microcirculatory blood flow, Other: Brachial artery blood flow, Other: Venous blood drawAge, biological sex, and prior health history (excluding cancer diagnosis) matched control for cancer patients |
| 5-FU Chemotherapy Cancer Survivor (Survivor) | – | Other: Arterial blood pressure, Other: Skin microcirculatory blood flow, Other: Brachial artery blood flow, Other: Venous blood drawCancer survivors who have not received cancer therapy during the past year but previously received 5-Fluorouracil chemotherapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed cancer patients who have received (or are scheduled to receive) 5-FU chemotherapy within the past 30 days (n=26) will enter the study soon after initiation of treatment. Newly diagnosed cancer patients receiving cancer treatment other than 5-FU (n=26; chemotherapy, radiotherapy, etc.) will enter into the study soon after initiation of treatment. Cancer survivors (n=26) who have previously received 5-FU but not within the year proceeding enrollment will be entered into the study. Age, sex, and health (n=26; excluding cancer) matched controls will be included in the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- (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
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 |
|---|---|---|
| Arterial blood pressureMeasured using an automated non-invasive finger cuff that obtains beat-by-beat blood pressure measurements via finger photoplesmography. Briefly, changes in artery diameter are detected through infrared light in the finger cuff. (Finometer Pro, FMS, The Netherlands). | Other | 5-FU Chemotherapy (Experimental), 5-FU Chemotherapy Cancer Survivor (Survivor), Age/Sex matched Control (Control), Non-5-FU Chemotherapy (Sub-Control) |
| Skin microcirculatory blood flowAssessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine and norepinepherine or phenylepherine via iontophoresis. | Other | 5-FU Chemotherapy (Experimental), 5-FU Chemotherapy Cancer Survivor (Survivor), Age/Sex matched Control (Control), Non-5-FU Chemotherapy (Sub-Control) |
| Brachial artery blood flowA GE Ultrasound System will be used to non-invasively assess brachial artery blood flow prior to and following a standard flow mediated dilation protocol. | Other | 5-FU Chemotherapy (Experimental), 5-FU Chemotherapy Cancer Survivor (Survivor), Age/Sex matched Control (Control), Non-5-FU Chemotherapy (Sub-Control) |
| Venous blood drawA venous blood sample from the antecubital vein or a vein in the back of the hand will be taken via venipuncure by a nurse or a certified phlebotomist at the beginning of the experimental visit. These blood samples will be analyzed for the presence of reactive oxygen species and inflammatory markers. | Other | 5-FU Chemotherapy (Experimental), 5-FU Chemotherapy Cancer Survivor (Survivor), Age/Sex matched Control (Control), Non-5-FU Chemotherapy (Sub-Control) |
Primary outcome
Cutaneous (skin) blood flow (%) following administration of vasoactive substances
Time frame: 1 day
Measured once in each group following administration of vasodilatory (Acetylcholine) and vasoconstrictive (Norepinepherine or Phenylephrine) substances.
Brachial artery flow mediated dilation (FMD)
Time frame: 1 day
Measured once in each group
1 secondary outcome
Arterial blood pressure
Time frame: 1 day
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 2 Sep 2025.
- Background: PubMed 19520246Yeh 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.
- Background: PubMed 29977352Sara 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.
- Background: PubMed 14581295Taniyama Y, Griendling KK. Reactive oxygen species in the vasculature: molecular and cellular mechanisms. Hypertension. 2003 Dec;42(6):1075-81. doi: 10.1161/01.HYP.0000100443.09293.4F. Epub 2003 Oct 27.
- Background: PubMed 25186061Polk 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.
- Background: PubMed 2040332Luwaert 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. doi: 10.1093/oxfordjournals.eurheartj.a059919.
- Background: PubMed 15033676Sudhoff 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. doi: 10.1093/annonc/mdh150.
- Background: PubMed 30091663Sutterfield 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Head and Neck Cancer, run by Kansas State University at 1 site in United States.
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 4 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 2 Sep 2025. 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 United States. 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?
Cutaneous (skin) blood flow (%) following administration of vasoactive substances (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042298, which also lists 7 linked publications.
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 2 Sep 2025.