Control of emesis in R-CHOP (Rituximab (R) - Cyclophosphamide (C), Doxorubicin (H), Vincristine (O), Prednisolone (P)

An observational study to evaluate chemotherapy induced nausea and vomiting control in non-Hodgkin lymphoma patients receiving R-CHOP

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611001269921

Enrollment

100

Registered

2011-12-12

Start date

2012-01-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results