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Laser Acupuncture Against Nausea in Children
This study is currently recruiting participants.
Verified by University Children Hospital Homburg, September 2007
Sponsors and Collaborators: University Children Hospital Homburg
University Hospital Tuebingen
Information provided by: University Children Hospital Homburg
ClinicalTrials.gov Identifier: NCT00528554
  Purpose

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
Nausea
Vomiting
Cancer
Procedure: laser acupuncture
Procedure: placebo laser acupuncture

MedlinePlus related topics: Acupuncture Cancer Nausea and Vomiting
U.S. FDA Resources
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

Further study details as provided by University Children Hospital Homburg:

Primary Outcome Measures:
  • episodes of retching/vomiting per day during 1 chemotherapy course [ Time Frame: 1 chemotherapy course (5 days) ]

Secondary Outcome Measures:
  • rescue antiemetic medication during 1 chemotherapy course [ Time Frame: 1 chemotherapy course (5 days) ]

Estimated Enrollment: 25
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
A: Active Comparator
Active laser acupuncture
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
B: Placebo Comparator
Placebo laser acupuncture
Procedure: placebo laser acupuncture
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0-17,
  • Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)

Exclusion Criteria:

  • Age older than 17 years,
  • Participation in another clinical trial on supportive care
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528554

Contacts
Contact: Sven Gottschling, MD +49 6841 1628399 kisgot@uniklinikum-saarland.de
Contact: Norbert Graf, MD, PhD +49 6841 1628397 kingra@uniklinikum-saarland.de

Locations
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            
Sponsors and Collaborators
University Children Hospital Homburg
University Hospital Tuebingen
Investigators
Principal Investigator: Sven Gottschling, MD University Children`s Hospital Homburg, Germany
Study Director: Norbert Graf, MD, PhD University Children`s Hospital Homburg, Germany
  More Information

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

Keywords provided by University Children Hospital Homburg:
CINV
chemotherapy induced nausea and vomiting (CINV)

Study placed in the following topic categories:
Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on January 15, 2009