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A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer

A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer - A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052322
Enrollment
135
Registered
2023-09-27
Start date
2023-09-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Upper gastrointestinal cancer

Interventions

None listed

Sponsors

Nagoya University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cases diagnosed with upper gastrointestinal cancer and scheduled for initial chemotherapy with HEC regimen containing Cisplatin 2. Cases diagnosed with upper gastrointestinal cancer and scheduled for initial chemotherapy with MEC regimen containing Oxaliplatin 3. Diagnosed with upper gastrointestinal cancer, chemotherapy containing HEC containing Cisplatin or MEC containing Oxaliplatin was performed, antiemetic therapy containing an NK1 receptor antagonist antiemetic other than fosnetupitant was performed, and in which vomiting cannot be controlled 4. Cases in which the physician has determined that evaluation of nausea and vomiting associated with chemotherapy is possible 5. Cases aged 20 years or older at the time of obtaining consent 6. Cases where triple-drug combination therapy (Fosnetupitant, Palonosetron, Dexamethasone) is planned

Exclusion criteria

Exclusion criteria: 1. Cases in which emetic events are observed due to factors other than cancer chemotherapy (e.g., emetic events due to passage obstruction due to the underlying disease, emetic events due to brain metastases) 2. Cases receiving continuous systemic administration of steroids exceeding 10 mg/day of prednisone equivalent. 3. Cases in which the attending physician determines that enrollment in this study is inappropriate 4. Cases with a history of hypersensitivity to the components of Fosnetupitant, Palonosetron, and Dexamethasone 5. Pregnant women or women who may be pregnant

Design outcomes

Primary

MeasureTime frame
Complete suppression rate of emesis within 168 hours from the start of treatment

Secondary

MeasureTime frame
Incidence of vomiting or nausea, degree of nausea, additional antiemetic measures, adverse events (according to Common Terminology Criteria for Adverse Events)

Countries

Japan

Contacts

Public ContactKoki Nakanishi

Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery

konakani@med.nagoya-u.ac.jp052-744-2249

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026