SiCK: Sickness Prior to Chemotherapy in Kids
Research type
Research Study
Full title
Prevalence of anticipatory nausea and vomiting in children undergoing cytotoxic chemotherapy for malignant disease the SiCK (Sickness prior to Chemotherapy in Kids) study
IRAS ID
171825
Contact name
Amanda J Friend
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 4 months, 26 days
Research summary
This project will aim to assess nausea and vomiting symptoms 24 hours prior to commencing a new chemotherapy cycle for all patients in our unit who consent to taking part in the study. The Pediatric Nausea Assessment Tool (PeNAT) will be used to assess symptoms of nausea in children aged 4-18, whilst caregiver reporting will be used to assess symptoms of nausea in children under 4 years old. Quantitative data (ie number of vomits) will be recorded for all age groups.
Data will be collected on patients’ age, gender, oncological diagnosis, treatment regimen and treatment cycle as well as any prescribed antiemetic therapy. We will also look at recollection of severity of nausea and vomiting in previous chemotherapy cycles by self report.
Primary outcome will be prevalence of anticipatory nausea and vomiting in the
cohort. Secondary outcomes will include acute (<24h) and delayed (>24h) nausea and vomiting, collected from patient/carer report diaries, and the use of rescue antiemetics, based on drug chart for inpatient, and diary entries for outpatient use.Our analysis will examine age and gender differences in prevalence and differences in prevalence between treatment regimens as stratified by expected intensity of N&V and cycles. We will also aim to determine whether those patients who experienced more severe nausea and vomiting symptoms in previous cycles are more likely to develop anticipatory symptoms, while acknowledgingthat this information will be partly from recollection and partly prospective data acquisition.
The study will be run over six months, and with a 75% response rate will include approximately 35 patients and 150 cycles of chemotherapy. Ethical approval will be sought from an NHS Ethics committee and considered by LHTH R&D and Paediatric Oncology Research Management groups.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0039
Date of REC Opinion
23 Mar 2015
REC opinion
Further Information Favourable Opinion