The Role of TRP Channels in CIPN

NCT04415892 | Recruiting

• 1 other identifier: CCP19-3307-CIPN
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Cinnamaldehyde; Capsaicin; Dermal Blood Flow; Fingers; Human; Reproducibility; Paclitaxel; Oxaliplatin; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (8)

• Characterization cinnamaldehyde

  The dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers.

  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

  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

  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

  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.

  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.

  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.

  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.

  Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin

Study Arms (7)

Healthy volunteers

OTHER

Young, healthy male volunteers to characterize the DBF changes upon cinnamaldehyde and capsaicin, including the reproducibility.

Other: Cinnamaldehyde and capsaicin

Paclitaxel Patients

OTHER

Group of patients after treatment with paclitaxel.

Other: Cinnamaldehyde and capsaicin

Paclitaxel Controls

OTHER

Group of healthy volunteers, matched for sex, age and BMI with the group of Paclitaxel Patients.

Other: Cinnamaldehyde and capsaicin

Oxaliplatin Patients

OTHER

Group of patients after treatment with oxaliplatin.

Other: Cinnamaldehyde and capsaicin

Oxaliplatin Controls

OTHER

Group of healthy volunteers, matched for sex, age and BMI with the group of Oxaliplatin Patients.

Other: Cinnamaldehyde and capsaicin

Longitudinal Paclitaxel Patients

OTHER

Group of patients who are treated with paclitaxel.

Other: Cinnamaldehyde and capsaicin

Longitudinal Oxaliplatin Patients

OTHER

Group of patients who are treated with oxaliplatin.

Other: Cinnamaldehyde and capsaicin

Interventions

Cinnamaldehyde and capsaicin OTHER

Topical application of cinnamaldehyde and capsaicin on the fingers

Healthy volunteers; Longitudinal Oxaliplatin Patients; Longitudinal Paclitaxel Patients; Oxaliplatin Controls; Oxaliplatin Patients; Paclitaxel Controls; Paclitaxel Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

cinnamaldehyde; Capsaicin

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Jan de Hoon, MD, PhD, MSc

  Center for Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heleen Marynissen, MD

CONTACT

+3216347014; heleen.marynissen@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)