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

Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Drug: Capsaicin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Vellore, Tamilnadu, India, 632004
      • Christian Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle	Within 15 days of chemotherapy
Vomiting	Number of participants with chemotherapy-induced vomiting that occurs after 24 hours of the first cycle	Within 15 days of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall chemotherapy-induced nausea and vomiting	Number of participants with both immediate and delayed chemotherapy-induced nausea and vomiting	Within 15 days of chemotherapy
Severity of chemotherapy-induced nausea and vomiting	Number of participants with severe, moderate and mild chemotherapy-induced nausea and vomiting	Within 15 days of chemotherapy
Use of rescue medication	Number of participants requiring rescue medication for nausea and vomiting	Within 15 days of chemotherapy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): May 14, 2022
• Study Completion (Actual): May 14, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Chemotherapy; Capsaicin; Nausea and Vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 11995 (Other Identifier: DAIDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD may be shared depending on prevailing local institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No