Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

Phase 3

Completed

• Conditions: Cervical Cancer; Nasopharyngeal Cancer; Chemotherapy-induced Nausea and Vomiting; Radiation-Induced Nausea and Vomiting; Antiemetic
• Interventions: Drug: Fosaprepitant; Drug: tropisetron; Drug: Dexamethasone

• Registration Number: NCT05564286
• Lead Sponsor: Shantou University Medical College

Brief Summary

The study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese cohort.

Detailed Description

The study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• histologically confirmed nasopharyngeal carcinoma (AJCC 8th stage II-IVa) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical FIGO stage Ib2-IVa;), planning to receive concurrent chemoradiotherapy),18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria

• took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fosaprepitant group	Fosaprepitant	Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
fosaprepitant group	tropisetron	Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
control group	Dexamethasone	The control group was delivered tropisetron 5mg and dexamethasone 5mg only.
fosaprepitant group	Dexamethasone	Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
control group	tropisetron	The control group was delivered tropisetron 5mg and dexamethasone 5mg only.

Primary Outcome Measures

Name	Time	Method
cumulative incidence of emesis overall phase	5 weeks	The primary endpoint of the study was the cumulative incidence of emesis overall phase (from 1st day of cycle 1 to 7th day of cycle 5, 7 days for one cycle).

Trial Locations

Locations (1)

Cancer Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China