Cervical Cancer, Nasopharyngeal Cancer, Chemotherapy-induced Nausea and Vomiting, Radiation-Induced Nausea and Vomiting, Antiemetic
Conditions
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.
Interventions
DRUGFosaprepitant
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 .
DRUGtropisetron
All patients received tropisetron 5mg on day 1.
DRUGDexamethasone
.All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
Sponsors
Shantou University Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed