Laser Acupuncture Against Nausea in Children

Not Applicable

• Conditions: Nausea; Vomiting; Cancer
• Interventions: Procedure: laser acupuncture; Procedure: placebo laser acupuncture

• Registration Number: NCT00528554
• Lead Sponsor: University Children Hospital Homburg

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-09
• Study Start: 2007-09
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Last Update Submitted: 2007-09-17
• Last Update Posted: 2007-09-18
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	laser acupuncture	Active laser acupuncture
B	placebo laser acupuncture	Placebo laser acupuncture

Primary Outcome Measures

Name	Time	Method
episodes of retching/vomiting per day during 1 chemotherapy course	1 chemotherapy course (5 days)

Secondary Outcome Measures

Name	Time	Method
rescue antiemetic medication during 1 chemotherapy course	1 chemotherapy course (5 days)

Trial Locations

Locations (2)

University Children's Hospital Tübingen; 🇩🇪 Tübingen, Baden-Wuerttemberg, Germany

University Children's Hospital Homburg; 🇩🇪 Homburg, Saarland, Germany