Plain English Summary
Background and study aims?
Nausea and vomiting are side effects that result from chemotherapy, which leads to enormous stress and strain on cancer patients. Other side effects may include reduced quality of life, strong weight loss or therapy avoidance. During treatment patients may learn to associate the hospitals environment (for example smells, sounds or even the sight of the clinic) with chemotherapy and develop additional side effects such as nausea and vomiting prior to infusion, called anticipatory nausea and vomiting. Despite medication anticipatory reactions occur in 30% to 59% of cases.
It should be possible to prevent such nausea and vomiting occurrences with a treatment called overshadowing. Overshadowing uses the principle that an unusual stimulus overlays usual stimuli. It can prevent a response to usual stimuli (such as hospital environments). The aim of the study is to examine the results of overshadowing on anticipatory nausea and vomiting in pediatric cancer patients.
Who can participate?
Participation is open to pediatric patients (4 years old and above) newly diagnosed with cancer. Participants cannot be included if they have mental health problems or gastrointestinal tract cancer.
What does the study involve?
Participants will be randomly allocated to one of two groups: two different types of candy tasting different prior to every chemotherapy infusion through three treatment cycles.
Participants will have to describe levels of discomfort, anxiety, adherence to treatment and quality of life in logs and questionnaires.
What are the possible benefits and risks of participating?
No side effects are expected. Conventional drugs against nausea and vomiting (called antiemetic) remain available during the whole study. If overshadowing works as in preliminary studies, participants should experience less nausea and vomiting and this may reduce the use of antiemetic drugs.
Where is the study run from?
The study is planned as a single centre study at University Hospital Kiel, Germany (Department of Pediatrics). If recruitment of participants turns out to be difficult, the study will also take place at the University Hospital of Lübeck, Germany.
When is the study starting and how long is it expected to run for?
The study is anticipated to start on 01/06/2013 and to end on 30/11/2015.
Who is funding the study?
The study is initially funded by University Medical Center Schleswig-Holstein, Campus Kiel, Germany. Additional external funding is in progress.
Who is the main contact?
Dr Friedemann Geiger
f.geiger@uksh.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2012-01-ANV-OS
Study information
Scientific title
Overshadowing as prevention of anticipatory nausea and vomiting in pediatric cancer patients - a randomized placebo controlled trial
Acronym
Study hypothesis
Overshadowing can prevent anticipatory nausea and vomiting
Ethics approval
Medical Faculty Ethics Committee of University of Kiel, Germany, 06 March 2012, ref: A168/11
Study design
Randomized placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pediatric oncology
Intervention
A randomized, double-blinded, placebo-controlled study in pediatric cancer patients treated with at least 3 chemotherapy cycles - Two arms: the experimental group will get salient candy and the control group flavorless placebo tablets prior to every infusion of chemotherapy.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
anticipatory nausea and vomiting (via patient administered discomfort logs)
Secondary outcome measures
1. Post-treatment nausea and vomiting (via patient administered discomfort logs)
2. Quality of life (via patient administered KINDL-R questionnaire), state-anxiety (via patient administered KAT-II, form P / STAI) and adherence (via ratings by medical personnel)
3. Relation between prevalence of post-treatment and anticipatory nausea and vomiting
4. Applicability of the overshadowing treatment in the hospitals daily routine
Overall trial start date
01/06/2013
Overall trial end date
30/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. New diagnosis
2. German speaking
3. Age from 4 years
4. Receiving 3 chemotherapy cycles
5. Intervals of 7 days in-between the single chemotherapy cycles
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. CNS or gastrointestinal tract cancer
2. Mental restrictions
3. Recurrent cancer
4. Prior radiotherapy
Recruitment start date
01/06/2013
Recruitment end date
30/11/2015
Locations
Countries of recruitment
Germany
Trial participating centre
General Pediatrics Department [Klinik für Allgemeine Pädiatrie]
Kiel
24105
Germany
Sponsor information
Organisation
University of Kiel (Germany)
Sponsor details
c/o Prof. Dr. Martin Schrappe
General Pediatrics Department [Klinik für Allgemeine Pädiatrie]
University Hospital of Schleswig-Holstein
Schwanenweg 20
Kiel
24105
Germany
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782493
Publication citations
-
Protocol
Geiger F, Wolfgram L, Overshadowing as prevention of anticipatory nausea and vomiting in pediatric cancer patients: study protocol for a randomized controlled trial., Trials, 2013, 14, 103, doi: 10.1186/1745-6215-14-103.