Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

Shantou University Medical College

Status and phase: Completed; Phase 3

Conditions: Radiation-Induced Nausea and Vomiting; Nasopharyngeal Cancer; Chemotherapy-induced Nausea and Vomiting; Antiemetic; Cervical Cancer

Treatments: Drug: tropisetron; Drug: Dexamethasone; Drug: Fosaprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT05564286

SUMC-Fosa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 2 patient groups

fosaprepitant group

Experimental group

Description:

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.

Treatment:

Drug: Fosaprepitant

Drug: Dexamethasone

Drug: tropisetron

control group

Active Comparator group

Description:

The control group was delivered tropisetron 5mg and dexamethasone 5mg only.

Treatment:

Drug: Dexamethasone

Drug: tropisetron