Chemotherapy-induced Peripheral NeuropathyNCT04415892
The Role of TRP Channels in CIPN
A study testing Cinnamaldehyde and capsaicin in people with Chemotherapy-induced Peripheral Neuropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Cinnamaldehyde and capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 21Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Heleen Marynissen, +3216342201, heleen.marynissen@uzleuven.be
About this study
Official title: The Role of Transient Receptor Potential Channels in Chemotherapy-Induced Peripheral Neuropathic Pain.
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.
Read the 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 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.
- Being tested
- Cinnamaldehyde and capsaicin
- Keywords
- Cinnamaldehyde, Capsaicin, Dermal Blood Flow, Fingers, Human, Reproducibility, Paclitaxel, Oxaliplatin, Peripheral Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamaldehyde and capsaicinOther
Topical application of cinnamaldehyde and capsaicin on the fingers
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Young, healthy male volunteers to characterize the DBF changes upon cinnamaldehyde and capsaicin, including the reproducibility. Receives: Other: Cinnamaldehyde and capsaicin |
| Paclitaxel Patients | Other | Group of patients after treatment with paclitaxel. Receives: Other: Cinnamaldehyde and capsaicin |
| Paclitaxel Controls | Other | Group of healthy volunteers, matched for sex, age and BMI with the group of Paclitaxel Patients. Receives: Other: Cinnamaldehyde and capsaicin |
| Oxaliplatin Patients | Other | Group of patients after treatment with oxaliplatin. Receives: Other: Cinnamaldehyde and capsaicin |
| Oxaliplatin Controls | Other | Group of healthy volunteers, matched for sex, age and BMI with the group of Oxaliplatin Patients. Receives: Other: Cinnamaldehyde and capsaicin |
| Longitudinal Paclitaxel Patients | Other | Group of patients who are treated with paclitaxel. Receives: Other: Cinnamaldehyde and capsaicin |
| Longitudinal Oxaliplatin Patients | Other | Group of patients who are treated with oxaliplatin. Receives: Other: Cinnamaldehyde and capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization cinnamaldehyde
The dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Oct 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan de Hoon, MD, PhD, MSc, Principal investigator, Center for Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415892
- Sponsor's protocol ID
- CCP19-3307-CIPN
- Status last verified
- Jun 2025
- First submitted
- 20 May 2020
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transient Receptor Potential Channels in Chemotherapy-Induced Peripheral Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT04415892
- Acronym / sponsor ID
- CCP19-3307-CIPN
- Keywords
- Cinnamaldehyde, Capsaicin, Dermal Blood Flow, Fingers, Human, Reproducibility, Paclitaxel, Oxaliplatin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Cinnamaldehyde and capsaicinYoung, healthy male volunteers to characterize the DBF changes upon cinnamaldehyde and capsaicin, including the reproducibility. |
| Paclitaxel Patients | Other | Other: Cinnamaldehyde and capsaicinGroup of patients after treatment with paclitaxel. |
| Paclitaxel Controls | Other | Other: Cinnamaldehyde and capsaicinGroup of healthy volunteers, matched for sex, age and BMI with the group of Paclitaxel Patients. |
| Oxaliplatin Patients | Other | Other: Cinnamaldehyde and capsaicinGroup of patients after treatment with oxaliplatin. |
| Oxaliplatin Controls | Other | Other: Cinnamaldehyde and capsaicinGroup of healthy volunteers, matched for sex, age and BMI with the group of Oxaliplatin Patients. |
| Longitudinal Paclitaxel Patients | Other | Other: Cinnamaldehyde and capsaicinGroup of patients who are treated with paclitaxel. |
| Longitudinal Oxaliplatin Patients | Other | Other: Cinnamaldehyde and capsaicinGroup of patients who are treated with oxaliplatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamaldehyde and capsaicinTopical application of cinnamaldehyde and capsaicin on the fingers | Other | Healthy volunteers, Longitudinal Oxaliplatin Patients, Longitudinal Paclitaxel Patients, Oxaliplatin Controls, Oxaliplatin Patients, Paclitaxel Controls, Paclitaxel Patients |
Primary outcome
Characterization cinnamaldehyde
Time frame: Dermal blood flow response measured during 60 minutes post-application
The dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers.
Inter-hand reproducibility cinnamaldehyde
Time frame: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 1
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
Inter-period reproducibility cinnamaldehyde
Time frame: Interval of at least 5 days between both periods
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
Characterization capsaicin
Time frame: Dermal blood flow response measured during 60 minutes post-application
The dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers
Inter-hand reproducibility capsaicin
Time frame: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 3
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.
Inter-period reproducibility capsaicin
Time frame: Interval of at least 5 days between both periods
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.
DBF patients compared to 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.
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.
DBF in patients before, during and after chemotherapeutic treatment
Time frame: Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Not yet recruitingPhase 2
Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
Breast Cancer, Peripheral Neuropathy Due to Chemotherapy
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Not yet recruiting
AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Active, not recruitingPhase 2
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel
Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy
Recruiting
Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan de Hoon, MD, PhD, MSc principal investigator
Center for Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamaldehyde and capsaicin in people with Chemotherapy-induced Peripheral Neuropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heleen Marynissen, MD (+3216347014, heleen.marynissen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization cinnamaldehyde (time frame: Dermal blood flow response measured during 60 minutes post-application). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.