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Laser Acupuncture Against Nausea in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by University Children Hospital Homburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by:
University Children Hospital Homburg
ClinicalTrials.gov Identifier:
NCT00528554
First received: September 11, 2007
Last updated: September 17, 2007
Last verified: September 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: A
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
Other Name: Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany
Placebo Comparator: B
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
Other Name: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

  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
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            
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

No publications provided

ClinicalTrials.gov Identifier: NCT00528554     History of Changes
Other Study ID Numbers: SG-07-HT-01
Study First Received: September 11, 2007
Last Updated: September 17, 2007
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013