Laser Acupuncture Against Nausea in Children

University Children Hospital Homburg

Status: Unknown

Conditions: Vomiting; Nausea; Cancer

Treatments: Procedure: laser acupuncture; Procedure: placebo laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00528554

SG-07-HT-01

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Active laser acupuncture

Treatment:

Procedure: laser acupuncture

B

Placebo Comparator group

Description:

Placebo laser acupuncture

Treatment:

Procedure: placebo laser acupuncture