Actively Recruiting
The Role of TRP Channels in CIPN
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
240
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of TRP Channels in CIPN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers must be white males aged 18 to 45 years.
- Healthy volunteers must have not smoked for at least 6 months before the study.
- Healthy volunteers must have a body mass index between 18 and 30 kg/m².
- Healthy volunteers must be in good health based on medical history, physical exam, and vital signs.
- Healthy volunteers must understand the study procedures and give written consent.
- Healthy volunteers must be matched to patient groups by sex, age, and BMI for Part II.
- Patients in Part II must be white males or females aged 18 to 70 years.
- Patients in Part II must have not smoked for at least 6 months before the study.
- Patients in Part II must have a BMI between 18 and 35 kg/m².
- Patients in Part II must have been treated with paclitaxel or oxaliplatin chemotherapy.
- Patients in Part II must have peripheral neuropathy grade 1, 2, or 3 according to the Total Neuropathy Score.
- Patients in Part II must have neuropathic symptoms in the upper limbs.
- Patients in Part II must have stopped chemotherapy more than 1 month and less than 1 year ago.
- Patients in Part II must understand the study procedures and give written consent.
- Patients in Part III must be white males or females aged 18 to 75 years.
- Patients in Part III must have not smoked for at least 6 months before the study.
- Patients in Part III must have a BMI between 18 and 35 kg/m².
- Patients in Part III must be scheduled to receive paclitaxel or oxaliplatin chemotherapy soon.
- Patients in Part III must understand the study procedures and give written consent.
You will not qualify if you...
- Having eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, grafts, or other skin abnormalities on the fingers.
- Excessive hair growth on the fingers.
- Inability to avoid excessive tanning that could cause sunburn during the study.
- History of severe drug allergies.
- Regular use of prescription or non-prescription drugs that might affect study results.
- Regular use of lotions, oils, depilatory products, makeup, or other topical treatments on the fingers that cannot be stopped during the study.
- Inability to avoid alcohol 24 hours before study visits, current illicit drug use, or history of drug or alcohol abuse.
- Inability to limit caffeinated beverages to no more than 4 cups per day and avoid them 24 hours before visits.
- Abnormal vital signs at screening after resting: heart rate less than 40 or higher than 100 beats per minute, diastolic blood pressure less than 50 or higher than 90 mmHg, systolic blood pressure less than 90 or higher than 140 mmHg.
- Participation in another clinical trial with an investigational drug within the last 4 weeks.
- Any condition that might interfere with safe or optimal study participation.
- History of illness that could affect study results.
- Peripheral neuropathy before chemotherapy treatment (for patients).
- History of diabetes, amyloidosis, vitamin B deficiency, or other disorders that may cause peripheral neuropathy (for patients in Parts II and III).
- History of central nervous system lesions causing neuropathic pain (for patients in Parts II and III).
- History of treatment with bortezomib, vincristine, or other drugs that may cause neuropathic pain (for patients in Parts II and III).
- No neuropathy development after epirubicin-cyclophosphamide treatment (for paclitaxel group in Part III).
- Family history of peripheral neuropathy (for patients in Parts II and III).
AI-Screening
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Trial Site Locations
Total: 1 location
1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
H
Heleen Marynissen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
7
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