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Sponsors and Collaborators: |
University Children Hospital Homburg University Hospital Tuebingen |
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Information provided by: | University Children Hospital Homburg |
ClinicalTrials.gov Identifier: | NCT00528554 |
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
Condition | Intervention |
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Nausea Vomiting Cancer |
Procedure: laser acupuncture Procedure: placebo laser acupuncture |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial |
Estimated Enrollment: | 25 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
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A: Active Comparator
Active laser acupuncture
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Procedure: laser acupuncture
laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course
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B: Placebo Comparator
Placebo laser acupuncture
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Procedure: placebo laser acupuncture
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
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Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sven Gottschling, MD | +49 6841 1628399 | kisgot@uniklinikum-saarland.de |
Contact: Norbert Graf, MD, PhD | +49 6841 1628397 | kingra@uniklinikum-saarland.de |
Germany, Baden-Wuerttemberg | |
University Children`s Hospital Tübingen | Recruiting |
Tübingen, Baden-Wuerttemberg, Germany, 72076 | |
Contact: Regina Braun, MD + 49 07071 80894 regibraun@gmx.de | |
Principal Investigator: Regina Braun, MD | |
Germany, Saarland | |
University Children`s Hospital Homburg | Recruiting |
Homburg, Saarland, Germany, 66421 | |
Contact: Sven Gottschling, MD +49 6841 1628399 kisgot@uniklinikum-saarland.de | |
Principal Investigator: Sven Gottschling, MD |
Principal Investigator: | Sven Gottschling, MD | University Children`s Hospital Homburg, Germany |
Study Director: | Norbert Graf, MD, PhD | University Children`s Hospital Homburg, Germany |
Study ID Numbers: | SG-07-HT-01 |
Study First Received: | September 11, 2007 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00528554 |
Health Authority: | Germany: Ethics Commission |
CINV chemotherapy induced nausea and vomiting (CINV) |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nausea |