The Role of TRP Channels in CIPN (NCT04415892) | Clinical Trial Compass
RecruitingNot Applicable
The Role of TRP Channels in CIPN
Belgium240 participantsStarted 2019-10-01
Plain-language summary
Part I:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in healthy, male volunteers. In addition, the inter-period and inter-hand reproducibility of the increase in dermal blood flow will be assessed.
Part II:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients suffering from chemotherapy-induced peripheral neuropathy compared to matched healthy volunteers.
Part III:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients who are treated with paclitaxel or oxaliplatin.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is a white male ≥18 and ≤45 years of age.
. Subject is a non-smoker for at least 6 months prior to the start of the study.
. Subject has a body mass index between 18-30 kg/m².
. Subject is judged to be in good health on the basis of medical history, physical examination and vital signs.
. Subject understands the procedures and agrees to participate in the study by giving written informed consent.
. Subject is matched to the patient groups for sex, age and BMI (only part II).
. Subject is a white male or female ≥18 and ≤70 years of age.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization cinnamaldehyde
Timeframe: Dermal blood flow response measured during 60 minutes post-application
2
Inter-hand reproducibility cinnamaldehyde
Timeframe: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 1
3
Inter-period reproducibility cinnamaldehyde
Timeframe: Interval of at least 5 days between both periods
4
Characterization capsaicin
Timeframe: Dermal blood flow response measured during 60 minutes post-application
5
Inter-hand reproducibility capsaicin
Timeframe: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 3
6
Inter-period reproducibility capsaicin
Timeframe: Interval of at least 5 days between both periods
. Subject is a non-smoker for at least 6 months prior to the start of the study.
Exclusion criteria
. Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps or grafts on their fingers or any other abnormality of the skin which, in the opinion of the investigator may interfere with the study assessments.
. Subject has excessive hair growth on the fingers.
. Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study.
. Subject has a history of significant severe (drug) allergies.
. Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study.
. Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the fingers on a regular basis which cannot be discontinued for the duration of the study.
. Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of any illicit drugs, or has a history of drug (including alcohol) abuse.
. Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
Timeframe: Dermal blood flow measured in patients who are suffering from CIPN 1 to 12 months after the last administration of paclitaxel or oxaliplatin.
8
DBF in patients before, during and after chemotherapeutic treatment
Timeframe: Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin