Extrait

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 [email protected]

Critère d'inclusion

• Pediatric oncology

Liens

• ictrp
• isrctn