Laser Acupuncture Against Nausea in Children

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00528554
• Other study ID #: SG-07-HT-01
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2007
• Last updated: September 17, 2007
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2007
• Source: University Children Hospital Homburg
• Contact: Sven Gottschling, MD
• Phone: +49 6841 1628399
• Email: kisgot[@]uniklinikum-saarland.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Nausea
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Germany	University Children`s Hospital Homburg	Homburg	Saarland
Germany	University Children`s Hospital Tübingen	Tübingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Children Hospital Homburg	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	episodes of retching/vomiting per day during 1 chemotherapy course		1 chemotherapy course (5 days)
Secondary	rescue antiemetic medication during 1 chemotherapy course		1 chemotherapy course (5 days)