Clinical trial · Interventional
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
NCT01909856CI-TRIAL-00020073completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Granisetron | Drug | — | UNRESOLVED |
| Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm1
- description
- 1st cycle Palonosetron, 2nd cycle Granisetron
- interventionNames
- Drug: Palonosetron
- Drug: Granisetron
- Drug: Dexamethasone
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Arm2
- description
- 1st cycle Granisetron, 2nd cycle Palonosetron
- interventionNames
- Drug: Palonosetron
- Drug: Granisetron
- Drug: Dexamethasone
- Drug: Cisplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol; * The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration; * Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy; * Life expectancy ≥ 3 months; * Adequate hematologic function; * Adequate hepatic function; * Adequate renal function; * At least 2 weeks away from the last chemotherapy; * Patients signed written informed consent. Exclusion Criteria: * Pregnant or lactating women; * History of anticipatory vomiting; * Radiation therapy on the abdomen or pelvis within one week prior to study entry; * Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.); * Patients with gastrointestinal obstruction; * Patients with severe heart disease, liver or renal disease, or metabolism disorders; * Patients with epilepsy or using sedative or psychotropic drugs; * Patients with diabetes or with contraindication for corticosteroids; * Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry; * Patients with brain metastasis or intracranial hypertension; * Hypersensitivity to 5-HT3 receptor antagonist; * Patients with active infection; * Other conditions that the investigator considered as unsuitable for chemotherapy; * Subjects participating in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.