Status:
RECRUITING
The Role of TRP Channels in CIPN
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
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 whi...
Eligibility Criteria
Inclusion
- Inclusion Criteria Healthy volunteers:
- 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).
- Inclusion Criteria Patients of 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.
- Subject has a BMI between 18-35 kg/m².
- Subject has a history of treatment with one of the following chemotherapeutic agents:
- Paclitaxel
- Oxaliplatin
- Subject suffers from peripheral neuropathy grade 1, 2 or 3 according to the Total Neuropathy Score (clinical version). Grade 1 correlates to a score of 1-7, grade 2 to a score of 8-14 and grade 3 to a score of 15-21(10-12).
- Subject suffers from neuropathic symptoms in the upper limbs.
- Discontinuation or termination of therapy with the chemotherapeutic agent occurred \>1 month and \< 1 year ago.
- Subject understands the procedures and agrees to participate in the study by giving written informed consent.
- Inclusion Criteria for patients of Part III
- Subject is a white male or female ≥18 and ≤75 years of age.
- Subject is a non-smoker for at least 6 months prior to the start of the study.
- Subject has a BMI between 18-35 kg/m².
- Subject will receive treatment with paclitaxel or oxaliplatin in the near future.
- Subject understands the procedures and agrees to participate in the study by giving written informed consent.
- 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.
- 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.
- Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg.
- Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
- Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study.
- Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study.
- Subject suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients).
- Subject has (a history of) diabetes mellitus, amyloidosis, vitamin B deficiency or any other medical disorder that, in the investigator's opinion, may cause peripheral neuropathy (only for Part II and III).
- Subject has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III).
- Subject has a history of treatment with bortezomib, vincristine, or any other compound that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III).
- Subject did not develop neuropathy after treatment with epirubicine-cyclofosfamide (only for the paclitaxel group in Part III).
- Subject has a family history of peripheral neuropathy (only for Part II and III).
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04415892
Start Date
October 1 2019
End Date
December 1 2024
Last Update
June 27 2024
Active Locations (1)
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1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000