Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

Sponsor

Shantou University Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT05564286

Collaborator

(none)

206

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Nasopharyngeal Cancer Chemotherapy-induced Nausea and Vomiting Radiation-Induced Nausea and Vomiting Antiemetic	Drug: Fosaprepitant Drug: tropisetron Drug: Dexamethasone	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Fosaprepitant Combined With Tropisetron Plus Dexamethasone in Preventing Nausea and Emesis During Fractionated Radiotherapy With Weekly Cisplatin Chemotherapy in Cervical Cancer and Nasopharyngeal Cancer

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fosaprepitant group 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.	Drug: Fosaprepitant In fosaprepitant group, patients would receive fosaprepitant combined with tropisetron plus dexamethasone to prevent chemoradiotherapy-induced nausea and vomitting while the control group would only be given tropisetron and dexamethasone . Other Names: shanqi Drug: tropisetron All patients received tropisetron 5mg on day 1. Other Names: luoting Drug: Dexamethasone .All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3. Other Names: xiluoan
Active Comparator: control group The control group was delivered tropisetron 5mg and dexamethasone 5mg only.	Drug: tropisetron All patients received tropisetron 5mg on day 1. Other Names: luoting Drug: Dexamethasone .All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3. Other Names: xiluoan

Arm

Intervention/Treatment

Experimental: fosaprepitant group

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.

Drug: Fosaprepitant

In fosaprepitant group, patients would receive fosaprepitant combined with tropisetron plus dexamethasone to prevent chemoradiotherapy-induced nausea and vomitting while the control group would only be given tropisetron and dexamethasone .

Other Names:

shanqi

Drug: tropisetron

All patients received tropisetron 5mg on day 1.

Other Names:

luoting

Drug: Dexamethasone

.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.

Other Names:

xiluoan

Active Comparator: control group

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

Drug: tropisetron

All patients received tropisetron 5mg on day 1.

Other Names:

luoting

Drug: Dexamethasone

.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.

Other Names:

xiluoan

Outcome Measures

Primary Outcome Measures

cumulative incidence of emesis overall phase [5 weeks]
the cumulative incidence of emesis from 1st day of cycle 1 to 7th day of cycly 5 of chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.