A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
18 Years
N/A
Both
Lymphoma, Non-Hodgkin
Trial Information
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Complete Response, Acute Phase (Day 1), Cycle 1
Outcome Description:
The proportion of patients experiencing a complete response defined as no vomiting and no use of breakthrough medication in the acute phase (day 1: 0 - 24 hours) of the first cycle of R-CHOP chemotherapy
Outcome Time Frame:
Day 1
Safety Issue:
No
Principal Investigator
Andrew Grigg, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Director of Clinical Haematology, Austin Hospital, Australia
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
ALLG SC03
NCT ID:
NCT01843868
Start Date:
May 2013
Completion Date:
December 2015
Related Keywords:
- Lymphoma, Non-Hodgkin
- Lymphoma
- Non-Hodgkin
- Emesis
- Chemotherapy
- Nausea
- Vomiting
- Aprepitant
- Lymphoma
- Lymphoma, Non-Hodgkin
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