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出境医 / 临床实验 / Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN) (CapCIN)

Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN) (CapCIN)

Study Description
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 and/or 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 NTS/AP. Only NK1 antagonists (e.g. 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 NTS/AP 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.


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Capsaicin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Capsaicin
2g of 0.075% topical capsaicin ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy
Drug: Capsaicin
Topical capsaicin ointment

Placebo Comparator: Placebo
2g of topical placebo ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy
Drug: Placebo
Topical placebo ointment

Outcome Measures
Primary Outcome Measures :
  1. Nausea [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle

  2. Vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with chemotherapy-induced vomiting that occurs after 24 hours of the first cycle


Secondary Outcome Measures :
  1. Overall chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with both immediate and delayed chemotherapy-induced nausea and vomiting

  2. Severity of chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with severe, moderate and mild chemotherapy-induced nausea and vomiting

  3. Use of rescue medication [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants requiring rescue medication for nausea and vomiting


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult chemotherapy naïve patients of at least 18 years old
  2. Diagnosed with a malignant disease and scheduled for highly emetogenic chemotherapy (as defined by NCCN guidelines v1.2019)
  3. No concurrent radiotherapy or use of other antiemetic drugs except (dexamethasone, ondansetron/granisetron, and olanzapine)
  4. Normal renal and hepatic function

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Contraindication for capsaicin or other medications in the study
  3. Has ongoing nausea and/or vomiting of other etiology
  4. History of anticipatory nausea and/or vomiting or has vomited/nauseated within 24 hours prior to the start of scheduled chemotherapy
  5. Chronic alcoholism
Contacts and Locations

Contacts
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Contact: Heber Rew Bright, MPharm +91 416 2282690 ext 2690 heberrewbright@hotmail.com

Locations
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India
Christian Medical College Recruiting
Vellore, Tamilnadu, India, 632004
Contact: Professor    +91 416 2284294 ext 4294    research@cmcvellore.ac.in   
Sponsors and Collaborators
Christian Medical College, Vellore, India
Investigators
Layout table for investigator information
Principal Investigator: Heber Rew Bright, MPharm Christian Medical College, Vellore, India
Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE October 18, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • Nausea [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle
  • Vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with chemotherapy-induced vomiting that occurs after 24 hours of the first cycle
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Nausea [ Time Frame: Within 15 days of chemotherapy ]
    Chemotherapy-induced nausea that occurs after 24 hours of the first cycle
  • Vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Chemotherapy-induced vomiting that occurs after 24 hours of the first cycle
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • Overall chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with both immediate and delayed chemotherapy-induced nausea and vomiting
  • Severity of chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants with severe, moderate and mild chemotherapy-induced nausea and vomiting
  • Use of rescue medication [ Time Frame: Within 15 days of chemotherapy ]
    Number of participants requiring rescue medication for nausea and vomiting
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Overall chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
    This includes both immediate and delayed chemotherapy-induced nausea and vomiting
  • Severity of chemotherapy-induced nausea and vomiting [ Time Frame: Within 15 days of chemotherapy ]
  • Use of rescue medication [ Time Frame: Within 15 days of chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN)
Official Title  ICMJE Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
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 and/or 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 NTS/AP. Only NK1 antagonists (e.g. 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 NTS/AP 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Chemotherapy-induced Nausea and Vomiting
Intervention  ICMJE
  • Drug: Capsaicin
    Topical capsaicin ointment
  • Drug: Placebo
    Topical placebo ointment
Study Arms  ICMJE
  • Experimental: Capsaicin
    2g of 0.075% topical capsaicin ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy
    Intervention: Drug: Capsaicin
  • Placebo Comparator: Placebo
    2g of topical placebo ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult chemotherapy naïve patients of at least 18 years old
  2. Diagnosed with a malignant disease and scheduled for highly emetogenic chemotherapy (as defined by NCCN guidelines v1.2019)
  3. No concurrent radiotherapy or use of other antiemetic drugs except (dexamethasone, ondansetron/granisetron, and olanzapine)
  4. Normal renal and hepatic function

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Contraindication for capsaicin or other medications in the study
  3. Has ongoing nausea and/or vomiting of other etiology
  4. History of anticipatory nausea and/or vomiting or has vomited/nauseated within 24 hours prior to the start of scheduled chemotherapy
  5. Chronic alcoholism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heber Rew Bright, MPharm +91 416 2282690 ext 2690 heberrewbright@hotmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04918069
Other Study ID Numbers  ICMJE 11995
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: IPD may be shared depending on prevailing local institutional policies.
Responsible Party Heber Rew Bright, Christian Medical College, Vellore, India
Study Sponsor  ICMJE Christian Medical College, Vellore, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heber Rew Bright, MPharm Christian Medical College, Vellore, India
PRS Account Christian Medical College, Vellore, India
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP