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

• Sponsor: Christian Medical College, Vellore, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT04918069
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.9
• Patients Per Site Per Month: 5.2

Study Details

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

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
• Actual Study Start Date: Oct 18, 2019
• Actual Primary Completion Date: May 14, 2022
• Actual Study Completion Date: May 14, 2022

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 [Within 15 days of chemotherapy]

   Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle

2. Vomiting [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 [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 [Within 15 days of chemotherapy]

   Number of participants with severe, moderate and mild chemotherapy-induced nausea and vomiting

3. Use of rescue medication [Within 15 days of chemotherapy]

   Number of participants requiring rescue medication for nausea and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Christian Medical College	Vellore	Tamilnadu	India	632004

Sponsors and Collaborators

• Christian Medical College, Vellore, India

Investigators

• Principal Investigator: Heber Rew Bright, MPharm, Christian Medical College, Vellore, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heber Rew Bright, Lecturer, Christian Medical College, Vellore, India
• ClinicalTrials.gov Identifier: NCT04918069
• Other Study ID Numbers: 11995
• First Posted: Jun 8, 2021
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heber Rew Bright, Lecturer, Christian Medical College, Vellore, India: Chemotherapy; Capsaicin; Nausea and Vomiting
• Additional relevant MeSH terms: Nausea; Vomiting; Capsaicin

Study Results

No Results Posted as of May 20, 2022