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

NCT ID: NCT04918069

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2022-05-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Capsaicin

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

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

Topical capsaicin ointment

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical placebo ointment

Interventions

Capsaicin

Topical capsaicin ointment

Intervention Type: DRUG

Placebo

Topical placebo ointment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christian Medical College, Vellore, India

OTHER

Sponsor Role: lead

Responsible Party

Heber Rew Bright

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heber Rew Bright, MPharm

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Locations

Christian Medical College

Vellore, Tamil Nadu, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 38905580 (View on PubMed)

Other Identifiers

11995

Identifier Type: -

Identifier Source: org_study_id