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A randomised controlled trial about the antiemetic effect of prolonged administration of fosaprepitant for lung cancer patients receiving 3 days cisplatin-based chemotherapy

A randomised controlled trial about the antiemetic effect of prolonged administration of fosaprepitant for lung cancer patients receiving 3 days cisplatin-based chemotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042665
Enrollment
Unknown
Registered
2021-01-26
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

study group:fosaprepitant 150mg IV, chemotherapy day1, 3
control group:fosaprepitant 150mg IV, chemotherapy day1

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with lung cancer confirmed by pathology (including NSCLC and SCLC); 2. Aged from 18 to 75 years; 3. ECOG physical condition score was 0-2; 4. Received chemotherapy ffr the first time, the chemotherapy regimen was cisplatin combined with one of the following drugs: paclitaxel, albumin paclitaxel, gemcitabine, vinorelbine, pemetrexed, etoposide; 5. Cisplatin administration regimen was given for three days; 6. Within 21 days after the beginning of the first cycle of chemotherapy, there was no radiotherapy, immunotherapy or targeted treatment plan (except bevacizumab and Endu). 7. No gastrointestinal and intestinal metastases, no brain metastases; 8. No history of chronic gastrointestinal diseases leading to recurrent nausea and vomiting, no history of chronic nausea and vomiting (such as vertigo, Meniere syndrome); 9. The indexes of hematology, liver and kidney function and important organ function met the requirements of chemotherapy; 10. The estimated survival time was more than 3 months; 11. Patients and their spouses were willing to take effective contraceptive measures; 12. Patients participated in the study voluntarily and were able to follow planned study visits, treatment plans, laboratory tests, and other research steps.

Exclusion criteria

Exclusion criteria: 1. Currently receiving treatment in other therapeutic clinical studies; 2. Had received systemic chemotherapy in the past; 3. Subjects who have not yet controlled stable cancer pain, need to titrate cancer pain or adjust the dose of opioid painkillers, or the digestive tract reaction of opioids has not been completely controlled; 4. Nausea and vomiting caused by whatever reason occurred within three days; 5. There is a history of active gastrointestinal ulcer and gastrointestinal bleeding within one year; 6. The subjects who could not read or could not complete the questionnaire independently; 7. No oral drugs; 8. Antiemetic drugs were given within 24 hours before chemotherapy, except for chemotherapy pretreatment, such as dexamethasone and diphenhydramine pretreatment before paclitaxel chemotherapy; 9. Patients with poor compliance and are not expected to complete the study as planned; 10. Patients who are known to be allergic to research drugs or ingredients; 11. Situations where other researchers believe that they cannot be included in the group.

Design outcomes

Primary

MeasureTime frame
the proportion of patients with CINV complete response;CINV fully protected days;Time to complete remission of CINV;frequence of emergency use anti-vomit medicine;Influence of life;adverse events;Rate of without nauseas;incidence of anticipated CINV before second cycleV the second cycle;

Countries

China

Contacts

Public ContactYanying Li

West China Hospital, Sichuan University

liyanying2001@163.com+86 13618025690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026