A prospective real-world study on the prevention of nausea and vomiting caused by concurrent chemoradiotherapy with cisplatin-based weekly regimens by dolasetron mesylate injection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500101688

Enrollment

Unknown

Registered

2025-04-28

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-05-05

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

Conditions

malignancy

Interventions

experimental group:30 ± 10 minutes before the start of chemotherapy drug infusion, 100 mg of Doralizumab Mesylate Injection was intravenously injected. For other antiemetic drugs, the decision was mad

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender not limited; 2. Malignant solid tumors diagnosed by pathological histology and/or cytology examination; 3. Planned to receive concurrent chemoradiotherapy with cisplatin-based weekly regimen in the first cycle, cisplatin administered once a week, radiotherapy 5 days a week; 4. Eastern Cooperative Oncology Group (ECOG) performance status score = 6 months; 6. The subjects are able to read, understand and complete the subject diary.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to dolasetron mesylate injection and its excipients; 2. Those who have been confirmed to have QT interval > 450 ms in the past, or have taken concomitant drugs due to prolonged QT interval, or have risk factors for prolonged QT interval or corresponding arrhythmia events (such as heart failure, hyperkalemia, history of long QT syndrome or family history); 3. Other situations that the investigators consider not eligible for inclusion.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects who did not experience vomitingduring the first cycle;	—

Secondary

Measure	Time frame
The proportion of subjects without nausea (with nausea VAS score <= 5 mm) and with mild nausea (with nausea VAS score <= 25 mm) in the first cycle;The severity of nausea in the first cycle (measured by the VAS scale);The proportion of subjects in the first cycle who did not use any rescue drugs;The response rate in the first cycle (CR);The time when the first episode of vomiting (vomiting or dry heaving) occurred or when rescue treatment was given (whichever occurred first) in the first cycle.;The incidence and severity of adverse events (AE) evaluated based on NCI-CTCAE 5.0 in the first cycle;	—

Measure

Time frame

The proportion of subjects without nausea (with nausea VAS score <= 5 mm) and with mild nausea (with nausea VAS score <= 25 mm) in the first cycle;The severity of nausea in the first cycle (measured by the VAS scale);The proportion of subjects in the first cycle who did not use any rescue drugs;The response rate in the first cycle (CR);The time when the first episode of vomiting (vomiting or dry heaving) occurred or when rescue treatment was given (whichever occurred first) in the first cycle.;The incidence and severity of adverse events (AE) evaluated based on NCI-CTCAE 5.0 in the first cycle;

—

Countries

China

Contacts

Public ContactZhang Song

First Affiliated Hospital of Zhengzhou University

zhangsong09@126.com+86 139 3716 6036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026