- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528554
Laser Acupuncture Against Nausea in Children
September 17, 2007 updated by: University Children Hospital Homburg
Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sven Gottschling, MD
- Phone Number: +49 6841 1628399
- Email: kisgot@uniklinikum-saarland.de
Study Contact Backup
- Name: Norbert Graf, MD, PhD
- Phone Number: +49 6841 1628397
- Email: kingra@uniklinikum-saarland.de
Study Locations
-
-
Baden-Wuerttemberg
-
Tübingen, Baden-Wuerttemberg, Germany, 72076
- Recruiting
- University Children's Hospital Tübingen
-
Contact:
- Regina Braun, MD
- Phone Number: + 49 07071 80894
- Email: regibraun@gmx.de
-
Principal Investigator:
- Regina Braun, MD
-
-
Saarland
-
Homburg, Saarland, Germany, 66421
- Recruiting
- University Children's Hospital Homburg
-
Contact:
- Sven Gottschling, MD
- Phone Number: +49 6841 1628399
- Email: kisgot@uniklinikum-saarland.de
-
Principal Investigator:
- Sven Gottschling, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Active 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 Names:
|
Placebo Comparator: B
Placebo laser acupuncture
|
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
episodes of retching/vomiting per day during 1 chemotherapy course
Time Frame: 1 chemotherapy course (5 days)
|
1 chemotherapy course (5 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rescue antiemetic medication during 1 chemotherapy course
Time Frame: 1 chemotherapy course (5 days)
|
1 chemotherapy course (5 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sven Gottschling, MD, University Children's Hospital Homburg, Germany
- Study Director: Norbert Graf, MD, PhD, University Children's Hospital Homburg, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
September 11, 2007
First Submitted That Met QC Criteria
September 11, 2007
First Posted (Estimate)
September 12, 2007
Study Record Updates
Last Update Posted (Estimate)
September 18, 2007
Last Update Submitted That Met QC Criteria
September 17, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SG-07-HT-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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