Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04918069
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2021-06-02
Brief Title:
Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting CapCIN
Sponsor:
Christian Medical College Vellore India
Organization:
Christian Medical College Vellore India
Study Overview
Official Title:
Single-blinded Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
Status:
COMPLETED
Status Verified Date:
2022-05
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:
CapCIN
Brief Summary:
Chemotherapy-induced nausea and vomiting CINV is one of the few most severe adverse effects of chemotherapy which often panic patients undergoing cancer treatment Though acute episodes of CINV are well controlled with pharmacologic agents delayed CINV continues to present a treatment challenge
Significant progress has been made over the past many years in discovering the pathophysiology of CINV Primarily three areas in the brain including central pattern generator CPG nucleus tractus solitarius NTS and area postrema AP are implicated in generating emetic reflex in all types of CINV anticipatory acute and delayed The latter two areas NTS and AP are located at the caudal end of the fourth ventricle of brain which lies outside of the blood brain barrier and hence are stimulated by agents present in either blood andor cerebrospinal fluid CSF Furthermore NTS and AP are rich in muscarinic dopamine serotonin neurokinin NK1 and histamine receptors which are particularly important in delayed CINV Clinical trials of antimuscarinic antidopaminergic antihistaminic drugs to prevent CINV have yielded inconclusive results except for olanzapine which is known to act on multiple receptors in NTSAP Only NK1 antagonists eg aprepitant which prevent substance P SP from binding to NK1 receptors have shown promising results and are clinically used to prevent delayed CINV SP is a tachykinin peptide encoded by TAC1 tachykinin precursor 1 gene and is found abundant in both peripheral and CNS NK1 receptors in NTSAP upon binding with SP will generate emetic reflex which will trigger delayed CINV Though the topical analgesic drug capsaicin is reported to interfere with endogenous SP its antiemetic potential in CINV has not been studied This study intend to explore the antiemetic potential of capsaicin which is known to interfere with SP release in the GIT and CNS
Significant progress has been made over the past many years in discovering the pathophysiology of CINV Primarily three areas in the brain including central pattern generator CPG nucleus tractus solitarius NTS and area postrema AP are implicated in generating emetic reflex in all types of CINV anticipatory acute and delayed The latter two areas NTS and AP are located at the caudal end of the fourth ventricle of brain which lies outside of the blood brain barrier and hence are stimulated by agents present in either blood andor cerebrospinal fluid CSF Furthermore NTS and AP are rich in muscarinic dopamine serotonin neurokinin NK1 and histamine receptors which are particularly important in delayed CINV Clinical trials of antimuscarinic antidopaminergic antihistaminic drugs to prevent CINV have yielded inconclusive results except for olanzapine which is known to act on multiple receptors in NTSAP Only NK1 antagonists eg aprepitant which prevent substance P SP from binding to NK1 receptors have shown promising results and are clinically used to prevent delayed CINV SP is a tachykinin peptide encoded by TAC1 tachykinin precursor 1 gene and is found abundant in both peripheral and CNS NK1 receptors in NTSAP upon binding with SP will generate emetic reflex which will trigger delayed CINV Though the topical analgesic drug capsaicin is reported to interfere with endogenous SP its antiemetic potential in CINV has not been studied This study intend to explore the antiemetic potential of capsaicin which is known to interfere with SP release in the GIT and CNS
Detailed Description:
None
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?:
None