Trials / Completed
CompletedNCT05564286
Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer
Fosaprepitant Combined With Tropisetron Plus Dexamethasone in Preventing Nausea and Emesis During Fractionated Radiotherapy With Weekly Cisplatin Chemotherapy in Cervical Cancer and Nasopharyngeal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Shantou University Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer
- Nasopharyngeal Cancer
- Chemotherapy-induced Nausea and Vomiting
- Radiation-Induced Nausea and Vomiting
- Antiemetic
Interventions
| Type | Name | Description |
|---|---|---|
| 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 . |
| DRUG | tropisetron | All patients received tropisetron 5mg on day 1. |
| DRUG | Dexamethasone | .All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3. |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2023-07-31
- Completion
- 2023-08-30
- First posted
- 2022-10-03
- Last updated
- 2024-02-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05564286. Inclusion in this directory is not an endorsement.