malignant lymphoma
Conditions
Interventions
None listed
Sponsors
Kyushu National Hospital Organization Pharmacists Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (at least 20 and up to 75 years of age) with malignant lymphoma (non-Hodgkin lymphoma) receiving CHOP (cyclophosphamide: 750 mg/m2, doxorubicin: 50 mg/m2, vincristine: 1.4 mg/m2 (maximum 2 mg), prednisolone: 100 mg/day) or Pola-R-CHP (cyclophosphamide: 750 mg/m2, doxorubicin: 50 mg/m2, polatuzumab vedotin: 1.8 mg/kg, rituximab: 375 mg/m2) as first-line therapy 2. Eastern Cooperative Oncology Group performance status of 0-2 3. No symptomatic brain metastases 4. No ascites or pleural effusion requiring puncture therapy 5. No gastrointestinal obstruction such as gastropyloric stenosis or intestinal obstruction 6. No severe organ damage and meet the following criteria based on blood tests within 2 weeks prior to registration: Alanine aminotransferase <100 IU/L Aspartate aminotransferase <100 IU/L Total bilirubin <2.0 mg/dL Serum creatinine <1.5 mg/dL 7. Patients who can accurately document symptom diary 8. Patients who provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with nausea and vomiting within 24-hours prior to initiation of chemotherapy 2. Patients receiving reduced doses of antineoplastic drugs 3. Patients receiving systemic steroids (except for use for disease control of the primary disease) 4. Patients regularly using antiemetic drugs other than 5-HT3 receptor antagonists and NK1 receptor antagonists 5. Patients receiving radiation therapy for the abdomen or pelvis within 1 week prior to initiation of chemotherapy 6. Started strong opioid analgesics within 48-hours before enrolment (dose modifications for drugs that have already been in use are permitted) 7. Patients deemed ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate, defined as no emetic episodes and no use of rescue medication for overall phase (0-120hr) following the initiation of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CR rate during acute phase (0-24hr), delayed phase (24-120hr), overall delayed phase (24-168hr), beyond delayed phase (120-168hr) and overall period (0-168hr). 2. Total control (TC) rate (defined as no emetic episodes, no rescue medication, and no nausea) rate for the overall phase, delayed phase, overall delayed phase, beyond delayed phase and overall period (0-168hr) 3. Factors associated with CR and TC rates 4. Amount of food intake 5. Frequency of rescue medication 6. Time to treatment failure 7. Adverse event (PRO-CTCAE) 8. Satisfaction with antiemetic therapy | — |
Countries
Japan
Contacts
Public ContactTakanori Miyoshi
National Hospital Organization Kyushu Medical Center Department of Pharmacy
Outcome results
None listed