Comparison between two different antiemetic regimens in patients treated with concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer : A Randomized, Double Blind, Controlled Clinical Trial

Efficacy And Safety Of Add On Aprepitant to standard antiemetic regimen for concurrent chemoradiotherapy induced nausea & vomiting in locally advanced head & neck squamous cell carcinoma : A Randomized, Double Blind, Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068878

Enrollment

Registered

2024-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Aprepitant with Standard Antiemetic Regimen: Standard Antiemetic Regimen (Ondansetron 16mg and Dexamethasone 12mg given IV on Day 1) before CCRT along with Capsule Aprepitant 125mg give

Eligibility

Inclusion criteria

Inclusion criteria: Histologically confirmed cases of squamous cell carcinoma in head & neck region with any stage between Stages III-IV B. Patients with ECOG performance status 0–1 Patients with adequate organ and bone marrow function. Patient is able to swallow tablets

Exclusion criteria

Exclusion criteria: •advanced stage malignancies(above Stage IVB) •History of nausea and emesis occurred 24h before the start of CCRT. •Conditions like severe cardiovascular, pulmonary, diabetic, mental, and other diseases. •Pregnant or lactating females. •Drug h/o corticosteroid or benzodiazepines. •History of Drug/Alcohol addictions. •N&V provoking conditions like brain metastasis, gastrointestinal obstruction, hypocalcemia;

Design outcomes

Primary

Measure	Time frame
Complete Response (CR) – defined as no emesis and no use of rescue therapy during concurrent chemoradiotherapy.Timepoint: Complete Response (CR) – defined as no emesis and no use of rescue therapy during concurrent chemoradiotherapy, noted in acute phase (first 24 hours) post CCRT and delayed phase (day2 to day 5) post CCRT.	—

Secondary

Measure	Time frame
-Complete Protection (CP) – defined as no emesis or no rescue medication and no more than mild nausea -Degree of nausea & vomiting measured using MAT scale -Treatment adherence with patients daily diary entry and MAT Scale assessment -Use of any rescue anti-emetic therapy (Rescue antiemetic therapy will be permitted for grade 3 nausea as per the NCI CTCAE version5 or poor anti-emetic effects which is emesis more than two times in 24hrs and continuous vomiting within 5 minutes)Timepoint: -Complete Protection (CP) – defined as no emesis or no rescue medication and no more than mild nausea during acute phase (first 24 hours) and delayed phase (day 2 to day 5) post CCRT -Degree of nausea & vomiting throughout acute and delayed phase -Treatment adherence with assessment during delayed phase -Use of any rescue anti-emetic therapy during acute and delayed phases	—

Measure

Time frame

-Complete Protection (CP) – defined as no emesis or no rescue medication and no more than mild nausea -Degree of nausea & vomiting measured using MAT scale -Treatment adherence with patients daily diary entry and MAT Scale assessment -Use of any rescue anti-emetic therapy (Rescue antiemetic therapy will be permitted for grade 3 nausea as per the NCI CTCAE version5 or poor anti-emetic effects which is emesis more than two times in 24hrs and continuous vomiting within 5 minutes)Timepoint: -Complete Protection (CP) – defined as no emesis or no rescue medication and no more than mild nausea during acute phase (first 24 hours) and delayed phase (day 2 to day 5) post CCRT -Degree of nausea & vomiting throughout acute and delayed phase -Treatment adherence with assessment during delayed phase -Use of any rescue anti-emetic therapy during acute and delayed phases

—

Countries

India

Contacts

Public ContactDr Neetu Gupta

Pt. B.D. Sharma PGIMS

neetu.kj13@gmail.com8826457679

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026