Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear.

This study aims to evaluate the overall effectiveness of antiemetic control using a standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron) in a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin Vincristine Cyclophosphamide Prednisolone).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australasian Leukaemia and Lymphoma Group
• Collaborators: Merck Sharp & Dohme (Australia) Pty Limited; Merck Sharp & Dohme Corp.
• Treatments: Antiemetics; Aprepitant; Cyclophosphamide; Doxorubicin; Emetics; Fosaprepitant; Granisetron; Lorazepam; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Metoclopramide; Ondansetron; Palonosetron; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prochlorperazine; Tropisetron; Vincristine

Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of non Hodgkin's Lymphoma

2. 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

3. 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.

4. Males and females, age 18 years or older

5. Are reasonably expected to be able to complete the CINV tool

6. Willing to complete assessments and tool as required for the study

7. ECOG (Eastern Cooperative Oncology Group) performance status score of 2 or less

8. Has provided written informed consent

Exclusion Criteria:

1. Women who are pregnant or lactating.

2. Previous adverse reaction to the standard anti-emetics proposed in the study

3. Contraindications to the use of the anti-emetics included as standard of care in the study (e.g. cardiac, liver function)

4. Participation in other therapeutic studies investigating CINV.

5. 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

6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.