The Role of TRP Channels in CIPN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cinnamaldehyde and capsaicin
Treatment groups
240 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov