Laser Acupuncture Against Nausea in Children | NCT00528554

Studies
Laser Acupuncture Against Nausea in Children

NCT00528554

Sponsor

University Children Hospital Homburg

Status

Unknown status

Last Update Posted

Sep 18, 2007Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Nausea
Vomiting
Cancer

Interventions

laser acupuncture
placebo laser acupuncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Sep 2009Estimated

First Submitted Date

Sep 11, 2007

First Submission Date that Met QC Criteria

Sep 11, 2007

First Posted Date

Sep 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2007

Last Update Posted Date

Sep 18, 2007Estimated

Name	Class
University Hospital Tuebingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Active laser acupuncture	Procedure: laser acupuncture
B	Placebo Comparator	Placebo laser acupuncture	Procedure: placebo laser acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laser acupuncture	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sven Gottschling, MD	Contact	+49 6841 1628399		kisgot@uniklinikum-saarland.de
Norbert Graf, MD, PhD	Contact	+49 6841 1628397		kingra@uniklinikum-saarland.de

Overall Officials

Name	Affiliation	Role
Sven Gottschling, MD	University Children's Hospital Homburg, Germany	Principal Investigator
Norbert Graf, MD, PhD	University Children's Hospital Homburg, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Tübingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting
D009369	Neoplasms

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided