CClinicalTrials.gg
Status unknownNCT00528554Updated Sep 18, 2007

Laser Acupuncture Against Nausea in Children

An interventional study of laser acupuncture and placebo laser acupuncture in Nausea, Vomiting and Cancer, sponsored by University Children Hospital Homburg. Status unknown at 2 sites in Germany. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2007-09-18.

Sponsored by University Children Hospital Homburg · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

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

02

Conditions studied

  • Nausea
  • Vomiting
  • Cancer

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Keywords

  • CINV
  • chemotherapy induced nausea and vomiting (CINV)
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's planned enrollment of 25 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

University Children Hospital Homburg is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Age older than 17 years,
  • Participation in another clinical trial on supportive care
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    A

    Active laser acupuncture

    Procedure: laser acupuncture

  • Placebo comparator
    B

    Placebo laser acupuncture

    Procedure: placebo laser acupuncture

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

    Also known as: Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany

  • Procedureplacebo laser acupuncture

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

    Also known as: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

06

What researchers measure

Primary outcomes

  1. episodes of retching/vomiting per day during 1 chemotherapy course

    Time frame: 1 chemotherapy course (5 days)

Secondary outcomes

  1. rescue antiemetic medication during 1 chemotherapy course

    Time frame: 1 chemotherapy course (5 days)

07

Study locations

2 of 2 sites recruiting
  • University Children's Hospital Tübingen
    Tübingen, Baden-Wuerttemberg 72076, Germany
    • Regina Braun, MD · Contact · regibraun@gmx.de · + 49 07071 80894
    • Regina Braun, MD · Principal investigator
    Recruiting
  • University Children's Hospital Homburg
    Homburg, Saarland 66421, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00528554
Lead sponsor
University Children Hospital Homburg
Collaborators
University Hospital Tuebingen
First posted
Sep 12, 2007
Start date
Sep 2007
Completion
Sep 2009 (estimated)
Last update
Sep 18, 2007

Study contacts

Sven Gottschling, MD
Contact
kisgot@uniklinikum-saarland.de
+49 6841 1628399
Norbert Graf, MD, PhD
Contact
kingra@uniklinikum-saarland.de
+49 6841 1628397
Sven Gottschling, MD
principal investigator · University Children's Hospital Homburg, Germany
Norbert Graf, MD, PhD
study director · University Children's Hospital Homburg, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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