Clinical trial NCT01843868: Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
Official title: A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Keywords: Lymphoma
Non-Hodgkin
Emesis
Chemotherapy
Nausea
Vomiting
Aprepitant
Lead sponsor: Australasian Leukaemia and Lymphoma Group
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: The aim of this study will be to investigate the incidence and severity of CINV in patients receiving R-CHOP for the treatment of non-Hodgkin lymphoma and standardised antiemetic prophylaxis.

The study hypothesises that the control of delayed nausea and emesis is suboptimal in a proportion of patients receiving R-CHOP regimens and that delayed CINV is not prevented by use of 5HT3 antagonists beyond the first day of use post-chemotherapy administration.

Participating institutions will prospectively collect data on the incidence of CINV, the severity of CINV, the use of break through/rescue medication for episodes of CINV uncontrolled by prescribed regular antiemetics, the effectiveness of additional measures used when previous CINV control has been inadequate (for example the use of aprepitant as an additional measure in subsequent cycles) and the major side-effects likely to be related to the antiemetics.

The analysis of these results will determine the incidence and severity of CINV in patients receiving R-CHOP and the effectiveness of the prescribed antiemetic regimens. Analysis will also determine if the control and incidence of CINV is a significant problem in defined subgroups of patients receiving R-CHOP and could inform the design of future research (or an extension of the current protocol) in this area. Sub groups for investigation will include patients with advanced disease, those with abdominal involvement, those receiving R-CHOP every 14 days versus every 21 days (R-CHOP14 versus R-CHOP21), those receiving 6 or 8 treatment cycles of R-CHOP, older patients, younger females etc. A potential randomised study evaluating the role of aprepitant could be contemplated in high risk groups.

Eligibility 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.

Primary outcomes:
measure: Complete Response, Acute Phase (Day 1), Cycle 1
timeFrame: Day 1
measure: Complete Response, Delayed Phase (Days 2 to 11), Cycle 1
timeFrame: Days 2 to 11
Secondary outcomes:
measure: Complete Response - Cycle 2 and beyond
timeFrame: Day 1 to Day 11
measure: No Significant Nausea - Cycle 2 and beyond
timeFrame: Day 1 to Day 11
measure: Failure of standard anti-emetic prophylaxis, Day 1 to Day 11, Cycle 1 and beyond
timeFrame: Day 1 to Day 11
measure: Frequency of common adverse events associated with anti-emetics
timeFrame: Day 1 to Day 11
measure: Severity of common adverse events associated with anti-emetics
timeFrame: Day 1 to Day 11
Other outcomes:
Locations:
Study officials:
affiliation: Director of Clinical Haematology, Austin Hospital, Australia
name: Andrew Grigg, Professor
role: PRINCIPAL_INVESTIGATOR
References: