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

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

Study Contact Backup

Study Locations

    • Baden-Wuerttemberg
      • Tübingen, Baden-Wuerttemberg, Germany, 72076
        • Recruiting
        • University Children's Hospital Tübingen
        • Contact:
        • Principal Investigator:
          • Regina Braun, MD
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Recruiting
        • University Children's Hospital Homburg
        • Contact:
        • 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:
  • 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
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
Other Names:
  • placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

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.

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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