Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 5:12 PM
Study NCT ID:
NCT04415892
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of TRP Channels in CIPN
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
The Role of Transient Receptor Potential Channels in Chemotherapy-Induced Peripheral Neuropathic Pain.
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: