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

NCT04918069 | Completed Phase 2 DMC

• 1 other identifier: 11995
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Chemotherapy; Capsaicin; Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall chemotherapy-induced nausea and vomiting

  Within 15 days of chemotherapy

• Severity of chemotherapy-induced nausea and vomiting

  Within 15 days of chemotherapy

• Use of rescue medication

  Within 15 days of chemotherapy

Study Arms (2)

Capsaicin

EXPERIMENTAL

2g of 0.075% topical capsaicin ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy

Drug: Capsaicin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Capsaicin DRUG

Topical capsaicin ointment

Capsaicin

Placebo DRUG

Topical placebo ointment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breast feeding
• Contraindication for capsaicin or other medications in the study
• Has ongoing nausea and/or vomiting of other etiology
• History of anticipatory nausea and/or vomiting or has vomited/nauseated within 24 hours prior to the start of scheduled chemotherapy
• Chronic alcoholism

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Related Publications (1)

• Bright HR, Singh A, Joel A, Georgy JT, John AO, Rajkumar P, Jiji H, Stehno-Bittel L, Samuel P, Chandy SJ. Randomized Placebo-Controlled Trial of Topical Capsaicin for Delayed Chemotherapy-Induced Nausea and Vomiting. JCO Glob Oncol. 2024 Jun;10:e2400130. doi: 10.1200/GO.24.00130.

  PMID: 38905580 DERIVED

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Heber Rew Bright, MPharm

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: October 18, 2019
• Primary Completion: May 14, 2022
• Study Completion: May 14, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

IN (1)