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Laser Acupuncture Against Nausea in Children

NCT ID: NCT00528554

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

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

Detailed Description

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Conditions

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Nausea Vomiting Cancer

Keywords

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CINV chemotherapy induced nausea and vomiting (CINV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Active laser acupuncture

Group Type ACTIVE_COMPARATOR

laser acupuncture

Intervention Type PROCEDURE

laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course

B

Placebo laser acupuncture

Group Type PLACEBO_COMPARATOR

placebo laser acupuncture

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

placebo laser acupuncture

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

Intervention Type PROCEDURE

Other Intervention Names

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Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University Children Hospital Homburg

OTHER

Sponsor Role lead

Principal Investigators

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Sven Gottschling, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Homburg, Germany

Norbert Graf, MD, PhD

Role: STUDY_DIRECTOR

University Children's Hospital Homburg, Germany

Locations

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University Children's Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

University Children's Hospital Homburg

Homburg, Saarland, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sven Gottschling, MD

Role: CONTACT

Phone: +49 6841 1628399

Email: [email protected]

Norbert Graf, MD, PhD

Role: CONTACT

Phone: +49 6841 1628397

Email: [email protected]

Facility Contacts

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Regina Braun, MD

Role: primary

Sven Gottschling, MD

Role: primary

Other Identifiers

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SG-07-HT-01

Identifier Type: -

Identifier Source: org_study_id