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Randomized Controlled Trial
Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Clin Cases. Aug 16, 2026; 14(23): 122960
Published online Aug 16, 2026. doi: 10.12998/wjcc.122960
Aprepitant as add-on to standard antiemetic regimen for concurrent chemoradiotherapy induced nausea vomiting in head and neck cancer
Neetu Gupta, Shailley Sehgal, Niti Mittal
Neetu Gupta, Department of Pharmacology, Pt. B D Sharma Postgraduate Institute of Medical Sciences, Rohtak 124001, India
Shailley Sehgal, Department of Radiation Oncology, Pt. B D Sharma Postgraduate Institute of Medical Sciences, Rohtak 124001, Haryana, India
Niti Mittal, Department of Pharmacology, Postgraduate Institute of Medical Sciences, Rohtak 124001, Haryana, India
Co-first authors: Neetu Gupta and Shailley Sehgal.
Author contributions: Gupta N performed the conceptualization, data curation, data analysis, manuscript writing, and revision of the manuscript; Mittal N performed the conceptualization, data analysis, manuscript writing, and revision of the manuscript; Sehgal S performed the conceptualization, data analysis, manuscript writing, and revision of the manuscript. The designation of two co-first authors is justified based on their equal and significant contributions to the conceptualization, execution, and communication of this study. Both authors have played pivotal roles in guiding the research, analyzing data, and ensuring the manuscript’s accuracy and completeness. This rationale highlights the collaborative effort and contribution of both authors, which aligns with the journal’s expectations for co-first authorship.
AI contribution statement: No AI tool was involved in the generation of research data, interpretation of results, or formulation of conclusions.
Institutional review board statement: This study was reviewed and approved by the Biomedical research ethics committee of Postgraduate Institute of Medical Sciences, Rohtak, Haryana (BREC/24/364 dated 10.04.2024).
Clinical trial registration statement: The trial was registered prospectively with the clinical trials registry of India (CTRI/2024/06/068878).
Informed consent statement: All patients who participated in this study provided written informed consent.
Conflict-of-interest statement: All authors declare that they have no conflicts of interest to disclose.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: No additional data are available.
Corresponding author: Niti Mittal, DM, Professor, Department of Pharmacology, Pt. B D Sharma Postgraduate Institute of Medical Sciences, Medical Road, Rohtak 124001, Haryana, India. drnitimittal@uhsr.ac.in
Received: May 7, 2026
Revised: July 5, 2026
Accepted: July 16, 2026
Published online: August 16, 2026
Processing time: 101 Days and 10.6 Hours
Abstract
BACKGROUND

There is dearth of literature with respect to specific antiemetic guidelines for the concurrent chemoradiotherapy (CCRT) induced nausea and vomiting. Evidence regarding the routine use of NK1 receptor antagonists in CCRT settings also remains limited.

AIM

To evaluate the efficacy and safety of aprepitant as add-on to standard antiemetic therapy (ondansetron and dexamethasone) for prevention of CCRT-induced nausea and vomiting in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC).

METHODS

This randomized, double-blind, placebo controlled clinical trial was conducted at a regional cancer institute in a public tertiary care hospital in North India. Treatment naïve patients with histologically confirmed LAHNSCC started on weekly cisplatin-based CCRT were randomized into 2 groups viz. Group A: Aprepitant plus standard antiemetic regimen; and Group B: Standard antiemetic regimen. Patients were followed up till four days after CCRT cycle. Primary outcome of complete response was assessed during acute (0-24 hours) and delayed phase (day 2-5). Secondary outcomes included complete protection (CP), degree of nausea and vomiting, rescue medication use and safety analysis.

RESULTS

Eighty-six patients were enrolled (43 per group). The aprepitant regimen significantly improved acute-phase complete response (97.7% vs 81.4%; P = 0.014). Delayed-phase complete response was numerically higher in the aprepitant group (74.4% vs 69.7%) but the difference was not statistically significant (P = 0.63). CP was better in the aprepitant group. Mean nausea intensity score and rescue medication use were lower in Group A. Both regimens were well tolerated with comparable adverse events.

CONCLUSION

Addition of aprepitant provides superior acute-phase control of CCRT-induced nausea and vomiting and improves nausea without compromising safety. Larger studies with multiple CCRT cycles are needed to further provide confirmatory evidence in this direction.

Keywords: Concurrent chemoradiotherapy; Aprepitant; Head and neck cancer; Antiemetic regimen; Complete response; Complete protection; Rescue medication

Core Tip: This is the first randomised, double-blind, placebo-controlled trial evaluating aprepitant as add-on to standard antiemetic therapy in locally advanced head and neck squamous cell carcinoma patients receiving weekly cisplatin-based concurrent chemoradiotherapy. Addition of aprepitant significantly improved acute-phase complete response (97.7% vs 81.4%), complete protection in both phases, and nausea intensity without compromising safety or tolerability, supporting consideration of neurokinin-1 receptor antagonists as part of antiemetic prophylaxis in this setting, while larger studies are needed to confirm benefits during the delayed phase.

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