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 range18 Years – 75 Years
SexALL
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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.
✓. 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.
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
7
DBF patients compared to healthy volunteers
Timeframe: Dermal blood flow measured in patients who are suffering from CIPN 1 to 12 months after the last administration of paclitaxel or oxaliplatin.
✕. 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.
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