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.
The primary aim is to investigate whether paclitaxel and/or oxaliplatin alter TRP channel functionality in vivo in human. TRP functionality can indirectly be assessed via dermal blood flow changes which are part of the so-called neurogenic inflammation, induced upon TRP activation. In vivo in human, TRP can be activated via topical application of cinnamaldehyde or capsaicin on the skin. In Part I of the study, the DBF changes upon topical application of cinnamaldehyde or capsaicin on the fingers will be characterized, including inter-period and inter-hand reproducibility. In Part II, patients who are suffering from chronic CIPN after treatment with paclitaxel or oxaliplatin are included. DBF changes upon cinnamaldehyde and capsaicin are compared to a matched control group. In Part III, DBF changes are assessed in patients prior to the first administration of taxol/oxaliplatin and at regular points in time during the dosage regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
Topical application of cinnamaldehyde and capsaicin on the fingers
KU Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGCharacterization 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-application
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 1
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 periods
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-application
Inter-hand reproducibility capsaicin
The within subject inter-hand reproducibility of 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 simultaneously on both hands during 60 minutes post-application during study visit 3
Inter-period reproducibility capsaicin
The within subject inter-period reproducibility (i.e. assessing changes) of the dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers.
Time frame: Interval of at least 5 days between both periods
DBF patients compared to healthy volunteers
The dermal blood flow changes upon topical application of cinnamaldehyde and capsaicin in patients suffering from chemotherapy-induced peripheral neuropathy compared to matched healthy volunteers.
Time frame: Dermal blood flow measured in patients who are suffering from CIPN 1 to 12 months after the last administration of paclitaxel or oxaliplatin.
DBF in patients before, during and after chemotherapeutic treatment
The dermal blood flow changes upon topical application of cinnamaldehyde and capsaicin in patients prior to, during and after treatment with either paclitaxel or oxaliplatin.
Time frame: Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin
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