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Laser Acupuncture Against Nausea in Children

NCT00528554 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2007-09-18

No results posted yet for this study

Summary

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

Conditions

Interventions

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

PROCEDURE

placebo laser acupuncture

laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • University Children Hospital Homburg

    lead OTHER

Principal Investigators

  • Sven Gottschling, MD · University Children's Hospital Homburg, Germany

  • Norbert Graf, MD, PhD · University Children's Hospital Homburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Completion
2009-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528554 on ClinicalTrials.gov