Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy
Brief summary
This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).
Interventions
DRUGPalonosetron
Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.
Sponsors
Gruppo Italiano Studio Linfomi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, \>18 years of age; * Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification); * Patients candidates to a initial chemotherapy treatment; * ECOG performance status of 0-1; * Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1; * Written informed consent; * Female of childbearing potential must be using reliable contraceptive measures; * Acceptable hepatic and renal functions; * Willing and able to complete the patient diary.
Exclusion criteria
* Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide \>1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification); * Diagnosis of Hodgkin's Disease or Leukemia; * Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation; * Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days; * Have received any investigational drugs within 30 days before study entry; * Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation); * Prior treatment with Palonosetron; * Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity; * Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase; * Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis; * Clinically relevant electrolyte abnormalities; * Have a known hypersensitivity to 5HT3 receptor antagonists; * Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy; * Female patients who are pregnant or breast feeding; * Inability to understand or cooperate with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) | 0-120 hours |
Secondary
| Measure | Time frame |
|---|---|
| number of emetic episodes | within the first 24 h after chemotherapy and 24-120 h |
| presence of nausea graded according to Likert scale | within the first 24 h after chemotherapy and 24-120 h |
| rate of Complete Response | within the first 24 h after chemotherapy and 24-120 h |
| patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS) | within the first 24 h after chemotherapy and 24-120 h |
| toxic effects of Palonosetron | within the first 24 h after chemotherapy and 24-120 h |
| time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) | within the first 24 h after chemotherapy and 24-120 h |
Countries
Italy
Outcome results
None listed