BridgeMD
New treatment option for Chemotherapy-induced Peripheral Neuropathy
Official title The Role of TRP Channels in CIPN
ClinicalTrials.gov ID: NCT04415892
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps or grafts on their fingers or any other abnormality...
- 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...
- Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the fingers on a regular basis which cannot be...
See the full eligibility criteria
Who can join
- 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). 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...
- 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. 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.
What rules you out
- 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...
- 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...
- Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate \ 100 beats/min, Diastolic Blood Pressure \ 90 mmHg, Systolic Blood Pressure \ 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.