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Laser Acupuncture Against Nausea in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by University Children Hospital Homburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528554
First Posted: September 12, 2007
Last Update Posted: September 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Tuebingen
Information provided by:
University Children Hospital Homburg
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00528554     History of Changes
Other Study ID Numbers: SG-07-HT-01
First Submitted: September 11, 2007
First Posted: September 12, 2007
Last Update Posted: September 18, 2007
Last Verified: September 2007

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


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