Abstract
BackgroundEmesis and nausea are side effects induced by chemotherapy. These effects lead to enormous stress and strain on cancer patients. Further consequences may include restrictions in quality of life, cachexia or therapy avoidance. Evidence suggests that cancer patients develop the side effects of nausea and vomiting in anticipation of chemotherapy. Contextual cues such as smell, sounds or even the sight of the clinic may evoke anticipatory nausea and vomiting prior to infusion. Anticipatory nausea and vomiting are problems that cannot be solved by administration of antiemetica alone.The purpose of the proposed randomized placebo-controlled trial is to use an overshadowing technique to prevent anticipatory nausea and vomiting and to decrease the intensity and duration of post-treatment nausea and vomiting. Furthermore, the effect on anxiety, adherence and quality of life will be evaluated.Methods/DesignFifty-two pediatric cancer patients will be evenly assigned to two groups: an experimental group and a control group. The participants, hospital staff and data analysts will be kept blinded towards group allocation. The experimental group will receive during three chemotherapy cycles a salient piece of candy prior to every infusion, whereas the control group will receive flavorless placebo tablets.DiscussionIf an effectiveness of the overshadowing technique is proven, implementation of this treatment into the hospitals’ daily routine will follow. The use of this efficient and economic procedure should aid a reduced need for antiemetics.Trial registrationCurrent Controlled Trials ISRCTN30242271/
Highlights
Emesis and nausea are side effects induced by chemotherapy
A reasonable proportion of this development can be attributed to progress in cytostatics
Cytostatics stimulate the area postrema, a circumventricular organ that lies outside the blood– brain barrier, stimulation of which can lead to vomiting [2]
Summary
Around 1,800 children (under 15 years old) per year develop cancer in Germany [1]. The chances of surviving childhood cancer have increased considerably in the past 30 years due to differentiated diagnostic and developments in the therapy regimes. For patients who receive moderate emetic-risk chemotherapy, not including a combination of anthracycline plus cyclophosphamide, palonosetron plus dexamethasone is recommended for prophylaxis of acute nausea and vomiting. Patients who receive moderately emetic chemotherapy known to be associated with a significant incidence of delayed nausea and vomiting should receive antiemetic prophylaxis for delayed emesis. The guidelines for the chemotherapy-induced prevention of nausea and vomiting for high and moderate risk in children states that all patients should receive antiemetic prophylaxis with a combination of a 5-HT3 receptor antagonist and dexamethasone. State anxiety is associated with incidence and severity of post-treatment vomiting, and varies inversely with the emetic potential of the chemotherapy regimen [7] This counterintuitive finding might be explained by psychological factors being relevant in the experience of posttreatment vomiting for regimens of low to moderate emetic potential while their impact might be reduced or minimal for regimens with high emetic potential. The subgoals were to investigate the overshadowing effect on patients’ quality of life, state anxiety and adherence; to survey the relation between prevalence of post-treatment and ANV; and to determine the applicability of the overshadowing treatment in the hospital’s daily routine
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