Overshadowing as prevention of anticipatory nausea and vomiting

ISRCTN ISRCTN30242271
DOI https://doi.org/10.1186/ISRCTN30242271
Secondary identifying numbers 2012-01-ANV-OS
Submission date
30/04/2012
Registration date
13/06/2012
Last edited
25/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 hospital’s 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

Contact information

Dr Friedemann Geiger
Scientific

General Pediatrics Department [Klinik für Allgemeine Pädiatrie]
University Hospital of Schleswig-Holstein
Schwanenweg 20
Kiel
24105
Germany

Study information

Study designRandomized placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOvershadowing as prevention of anticipatory nausea and vomiting in pediatric cancer patients - a randomized placebo controlled trial
Study objectivesOvershadowing can prevent anticipatory nausea and vomiting
Ethics approval(s)Medical Faculty Ethics Committee of University of Kiel, Germany, 06 March 2012, ref: A168/11
Health condition(s) or problem(s) studiedPediatric oncology
InterventionA 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 typeOther
Primary outcome measureanticipatory nausea and vomiting (via patient administered discomfort logs)
Secondary outcome measures1. 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 hospital’s daily routine
Overall study start date01/06/2013
Completion date30/11/2015

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. CNS or gastrointestinal tract cancer
2. Mental restrictions
3. Recurrent cancer
4. Prior radiotherapy
Date of first enrolment01/06/2013
Date of final enrolment30/11/2015

Locations

Countries of recruitment

  • Germany

Study participating centre

General Pediatrics Department [Klinik für Allgemeine Pädiatrie]
Kiel
24105
Germany

Sponsor information

University of Kiel (Germany)
University/education

c/o Prof. Dr. Martin Schrappe
General Pediatrics Department [Klinik für Allgemeine Pädiatrie]
University Hospital of Schleswig-Holstein
Schwanenweg 20
Kiel
24105
Germany

Website http://www.uni-kiel.de/
ROR logo "ROR" https://ror.org/04v76ef78

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/04/2013 Yes No