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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
116
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 .
All patients received tropisetron 5mg on day 1.
.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
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).
Time frame: 5 weeks
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