To investigate whether nonthermal low level laser acupuncture has beneficial effects on nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in an otherwise similar setting we found beneficial effects, but this trial was not even single-blinded and therefore the results are questionable. The hypothesis is that active laser acupuncture is more effective than placebo laser acupuncture concerning episodes of retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary outcome measure) with a fix standard antiemetic medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
25
laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
University Children's Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGUniversity Children's Hospital Homburg
Homburg, Saarland, Germany
RECRUITINGepisodes of retching/vomiting per day during 1 chemotherapy course
Time frame: 1 chemotherapy course (5 days)
rescue antiemetic medication during 1 chemotherapy course
Time frame: 1 chemotherapy course (5 days)
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