Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
Lymphoma, Non-Hodgkin
About this trial
This is an interventional supportive care trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Non-Hodgkin, Emesis, Chemotherapy, Nausea, Vomiting, Aprepitant
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of non Hodgkin's Lymphoma
- Newly diagnosed or relapsed patients who are chemotherapy-naïve or who have not received chemotherapy in the last 12 months. Pre-phase therapy with prednisolone and/or vincristine for < one week duration prior to commencement of cycle 1 of R-CHOP is permissible
- Intended to receive R-CHOP every 14 or 21 days for minimum 3 cycles with rituximab planned to be given with CHOP on day 1 or fractionated over days 1 and 21.
- Males and females, age 18 years or older
- Are reasonably expected to be able to complete the CINV tool
- Willing to complete assessments and tool as required for the study
- ECOG (Eastern Cooperative Oncology Group) performance status score of 2 or less
- Has provided written informed consent
Exclusion Criteria:
- Women who are pregnant or lactating.
- Previous adverse reaction to the standard anti-emetics proposed in the study
- Contraindications to the use of the anti-emetics included as standard of care in the study (e.g. cardiac, liver function)
- Participation in other therapeutic studies investigating CINV.
- Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
Sites / Locations
Arms of the Study
Arm 1
Other
R-CHOP and standard anti-emetics
This is a single arm study. All patients receive R-CHOP every 14 or 21 days for a minimum of 3 cycles. Standard anti-emetics will be used as follows: 5HT3 (5-Hydroxytryptamine 3) antagonists (ondansetron, granisetron or tropisetron) used as the local institutional standard of care will be permitted, although the preferential use of ondansetron or granisetron will be encouraged. Dexamethasone will not to be used as patients receive hydrocortisone and oral prednisolone in R-CHOP. In this study, the use of oral prednisolone on day 1 will be regarded as equivalent to dexamethasone. Prednisolone will be given PRIOR to the chemotherapy with the 5HT3 antagonist. Anti-emetics (metoclopramide, prochlorperazine and lorazepam) may be prescribed to be used 'as needed' for breakthrough emesis. Patients 'failing' the standard Chemotherapy Induced Nausea and Vomiting prophylactic regimen will be eligible to receive aprepitant (Days 1 to 3) for subsequent cycles.