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A real-world study on the application of oral aprepitant combined with ondansetron in the treatment of breast cancer antibody-drug conjugates

A real-world study on the application of oral aprepitant combined with ondansetron in the treatment of breast cancer antibody-drug conjugates

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109080
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

breast cancer

Interventions

Experimental group:None

Sponsors

Liaoning Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient/family member signs the informed consent form and voluntarily participates in this study; 2. Age >= 18 years old, gender not restricted; 3. Patients with malignant tumors diagnosed by pathology or histopathology (including solid tumors and malignant hematological tumors); 4. Plan to use highly or moderately emetogenic chemotherapy drugs that comply with the NCCN guidelines and the guidelines for preventing vomiting related to anti-tumor treatment; 5. Have not received radiotherapy or chemotherapy within 2 weeks before participating in the trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with severe liver, kidney and cardiac function abnormalities; 3. Patients who have experienced vomiting within 24 hours before chemotherapy; 4. Patients allergic to NK-1 RA and/or its excipients; 5. Patients with nausea and vomiting caused by non-tumor factors, who are currently taking other emetogenic drugs or are suffering from alcohol poisoning;

Design outcomes

Primary

MeasureTime frame
During the treatment period (0 - 120 hours), the proportion of subjects who achieved complete remission (without vomiting and without receiving rescue treatment);

Secondary

MeasureTime frame
The proportion of subjects achieving complete remission during the acute phase (0 - 24 hours) and the delayed phase (25 - 120 hours);;During the treatment process, the proportion of patients who had previously received radiotherapy and achieved complete control (without vomiting, without rescue treatment, and without mild nausea (VAS < 25mm)) among the subjects;;The proportion of patients experiencing different levels of nausea/vomiting within different time periods;The proportion of subjects who received remedial treatment;Up to the time of treatment failure (based on the time of the first vomiting episode or the time of the remedial treatment, whichever occurs first);The changes in FLIE scores before and after treatment;Changes in the Hospital Anxiety and Depression Scale (HAD) scores before and after treatment;

Countries

China

Contacts

Public ContactJiang Lei

Liaoning Cancer Hospital and Institute

lovelongmao@163.com+86 138 8912 8372

Outcome results

None listed

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