Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001269921
Ethics application status
Approved
Date submitted
6/12/2011
Date registered
12/12/2011
Date last updated
25/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Control of emesis in R-CHOP (Rituximab (R) - Cyclophosphamide (C), Doxorubicin (H), Vincristine (O), Prednisolone (P)
Scientific title
An observational study to evaluate chemotherapy induced nausea and vomiting control in non-Hodgkin lymphoma patients receiving R-CHOP
Secondary ID [1] 273557 0
NCT01843868
Universal Trial Number (UTN)
U1111-1124-3472
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and Vomiting in R-CHOP patients with Non-Hodgkin Lymphoma 279325 0
Condition category
Condition code
Cancer 279511 279511 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this sudy, it is intended to observe the incidence of chemotherapy-induced nausea and vomiting (CINV), the severity of CINV, the effectiveness of additional measures for inadequate control of CINV e.g. the use of rescue therapy and the use of aprepitant in subsequent cycles, and the major side-effects likely to be related to anti-emetics.

The duration of this observational study will be approximately 18 months from the start of accrual to the end of treatment, with no follow-up.
Intervention code [1] 283838 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286077 0
The primary objective is to evaluate the overall effectiveness of a standardised 5HT3 antagonist-containing regimen as anti-emetic control in non-Hodgkin lymphoma patients following initiation of (R)-CHOP chemotherapy.

Effectiveness will be measured by the proportion of patients achieving a complete response (defined as no vomiting and no use of rescue medication) throughout the acute phase (day 1; 0 - 24 hours) and the proportion of patients achieving a complete response throughout the delayed phase (Days 2 (>24 hours) to 11) of the first cycle of chemotherapy.
Timepoint [1] 286077 0
End of study; two years from registration
Secondary outcome [1] 295083 0
To evaluate incidence and severity of CINV in the acute and delayed phases patients receiving (R)-CHOP for non-Hodgkin lymphoma across all cycles chemotherapy.

The incidence and severity of nausea and the incidence of vomiting and use of rescue therapy in the acute and delayed phases will be monitored using a patient self-assessment CINV diary that requires the patient to record their experience of CINV.
Timepoint [1] 295083 0
On-going, for the duration of the trial
Secondary outcome [2] 295084 0
To determine the frequency of use of aprepitant as secondary prophylaxis after the first chemotherapy cycle and to evaluate its effectiveness in controlling CINV when added to a standard anti-emetic regimen following failure to control CINV.

Failure of standard anti-emetic prophylaxis in any one cycle of chemotherapy requiring aprepitant as secondary prophylaxis in subsequent cycles. Failure will be defined as the occurrence of any of the following either during or beyond cycle day 1:

One or more episodes of vomiting or dry retching

One or more episodes of nausea requiring the use of 1 or more doses of breakthrough anti-emetics

An episode of nausea requiring the use of breakthrough anti-emetics across multiple days

An episode of nausea measuring > 2.5cm on a 0 - 10cm VAS

Nausea and/or vomiting that in the clinicians opinion requires use of aprepitant in future cycles.
Timepoint [2] 295084 0
on-going, for the duration of the trial
Secondary outcome [3] 295085 0
To investigate and identify patient, disease and chemotherapy scheduling characteristics as prognostic factors for CINV control in the acute and delayed phases of the first cycle of R-CHOP chemotherapy.
Timepoint [3] 295085 0
on-going, for the duration of the trial
Secondary outcome [4] 295086 0
To collect and summarise information on institutional standard of care.
Timepoint [4] 295086 0
on-going, for the duration of the trial
Secondary outcome [5] 295087 0
To identify frequency and severity of common side effects of anti-emetics.

The side effects (all grades) of the anti-emetic regimen will be monitored in each cycle of R-CHOP chemotherapy
Timepoint [5] 295087 0
on-going, for the duration of the trial

Eligibility
Key inclusion criteria
Chemotherapy-naive or those who have not received chemotherapy in the last 12 months;

Histologically confirmed diagnosis of NHL;

Intended to receive (R)-CHOP every 14 or 21 days for a minimum of 3 cycles;

Able to provide informed consent;

Are reasonably expected to be able to complete the CINV diary.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant or lactating;

Previous exposure to chemotherapy, excluding oral alkylator therapy or single agent rituximab more than 12 months previously;

Prior radiotherapy within 12 months;

Use of concomitant medication with Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride);

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 and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial;

Age < 18 years.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284314 0
Other
Name [1] 284314 0
Australasian Leukaemia and Lymphoma Group
Country [1] 284314 0
Australia
Funding source category [2] 284335 0
Commercial sector/Industry
Name [2] 284335 0
Merck Sharp & Dohme (Australia) Pty Limited
Country [2] 284335 0
Australia
Primary sponsor type
Other
Name
Australasian Leukaemia and Lymphoma Group
Address
Level 6, 372 Albert St
East Melbourne, Victoria, 3002
Country
Australia
Secondary sponsor category [1] 283257 0
Commercial sector/Industry
Name [1] 283257 0
Merck Sharp & Dohme (Australia) Pty Limited
Address [1] 283257 0
Level 4, 66 Waterloo Rd, North Ryde NSW 2113
Country [1] 283257 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286295 0
Tasmania Health and Medical HREC
Ethics committee address [1] 286295 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, Tasmania
Ethics committee country [1] 286295 0
Australia
Date submitted for ethics approval [1] 286295 0
20/05/2013
Approval date [1] 286295 0
20/05/2013
Ethics approval number [1] 286295 0

Summary
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 antagonist-containing regimen (e.g. ondansetron) in a heterogeneous group of patients receiving R-CHOP chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33122 0
Ms Christine Carrington
Address 33122 0
Cancer Services, Princess Alexandra Hospital, Brisbane, QLD
Country 33122 0
Australia
Phone 33122 0
+61 7 3176 6126
Fax 33122 0
Email 33122 0
[email protected]
Contact person for public queries
Name 16369 0
Ms Delaine Smith
Address 16369 0
Level 6, 372 Albert St
East Melbourne, Victoria
3002
Country 16369 0
Australia
Phone 16369 0
+613 9656 2760
Fax 16369 0
+ 61 3 9656 2779
Email 16369 0
[email protected]
Contact person for scientific queries
Name 7297 0
Ms Christine Carrington
Address 7297 0
Cancer Services, Princess Alexandra Hospital, Brisbane, QLD
Country 7297 0
Australia
Phone 7297 0
+61 7 3176 6126
Fax 7297 0
+617 3176 2252
Email 7297 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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