Laser Acupuncture Against Nausea in Children

Study Overview
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Brief Summary
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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

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

Conditions
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Nausea, Vomiting, Cancer

Intervention / Treatment
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* Procedure: laser acupuncture
* Procedure: placebo laser acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Active laser acupuncture | Procedure: laser acupuncture<br>* laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course<br>* Other names: Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany;|
| Placebo Comparator: B<br>Placebo laser acupuncture | Procedure: placebo laser acupuncture<br>* laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course<br>* Other names: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| episodes of retching/vomiting per day during 1 chemotherapy course |  | 1 chemotherapy course (5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rescue antiemetic medication during 1 chemotherapy course |  | 1 chemotherapy course (5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CINV, chemotherapy induced nausea and vomiting (CINV)