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Laser Acupuncture Against Nausea in Children

Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00528554
Enrollment
25
Registered
2007-09-12
Start date
2007-09-30
Completion date
2009-09-30
Last updated
2007-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Nausea, Vomiting

Keywords

CINV, chemotherapy induced nausea and vomiting (CINV)

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

Interventions

PROCEDURElaser 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

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

Sponsors

University Hospital Tuebingen
CollaboratorOTHER
University Children Hospital Homburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
episodes of retching/vomiting per day during 1 chemotherapy course1 chemotherapy course (5 days)

Secondary

MeasureTime frame
rescue antiemetic medication during 1 chemotherapy course1 chemotherapy course (5 days)

Countries

Germany

Contacts

Primary ContactSven Gottschling, MD
kisgot@uniklinikum-saarland.de+49 6841 1628399
Backup ContactNorbert Graf, MD, PhD
kingra@uniklinikum-saarland.de+49 6841 1628397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026