Condition category
Cancer
Date applied
30/04/2012
Date assigned
13/06/2012
Last edited
25/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Friedemann Geiger

ORCID ID

Contact details

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

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 measures

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 hospital’s daily routine

Overall trial start date

01/06/2013

Overall trial end date

30/11/2015

Reason abandoned

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

http://www.uni-kiel.de/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782493

Publication citations

  1. 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.

Additional files

Editorial Notes