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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cinnamaldehyde and capsaicin
Other interventionTopical application of cinnamaldehyde and capsaicin on the fingers
Treatment groups
240 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Healthy volunteersOther 1 intervention
Group B: Paclitaxel PatientsOther 1 intervention
Group C: Paclitaxel ControlsOther 1 intervention
Group D: Oxaliplatin PatientsOther 1 intervention
Group E: Oxaliplatin ControlsOther 1 intervention
Group F: Longitudinal Paclitaxel PatientsOther 1 intervention
Group G: Longitudinal Oxaliplatin PatientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Characterization cinnamaldehyde
The dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers.
Time frame
Dermal blood flow response measured during 60 minutes post-application2
Inter-hand reproducibility cinnamaldehyde
The within subject inter-hand reproducibility of the dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers
Time frame
Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 13
Inter-period reproducibility cinnamaldehyde
The within subject inter-period reproducibility (i.e. assessing changes) of the dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers
Time frame
Interval of at least 5 days between both periods4
Characterization capsaicin
The dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers
Time frame
Dermal blood flow response measured during 60 minutes post-applicationSponsors and contacts
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Source ClinicalTrials.gov