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NCT05564286 Clinical Trial

Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05564286
Other study ID # SUMC-Fosa
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2021
Est. completion date August 30, 2023

Study information
Verified date February 2024
Source Shantou University Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date August 30, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Cancer Hospital of Shantou University Medical College Shantou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary cumulative incidence of emesis overall phase 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). 5 weeks
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