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Laser Acupuncture Against Nausea in Children

Primary Purpose

Nausea, Vomiting, Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
laser acupuncture
placebo laser acupuncture
Sponsored by
University Children Hospital Homburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring CINV, chemotherapy induced nausea and vomiting (CINV)

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Children's Hospital TübingenRecruiting
  • University Children's Hospital HomburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Active laser acupuncture

Placebo laser acupuncture

Outcomes

Primary Outcome Measures

episodes of retching/vomiting per day during 1 chemotherapy course

Secondary Outcome Measures

rescue antiemetic medication during 1 chemotherapy course

Full Information

First Posted
September 11, 2007
Last Updated
September 17, 2007
Sponsor
University Children Hospital Homburg
Collaborators
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00528554
Brief Title
Laser Acupuncture Against Nausea in Children
Official Title
Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Children Hospital Homburg
Collaborators
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Cancer
Keywords
CINV, chemotherapy induced nausea and vomiting (CINV)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Active laser acupuncture
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo laser acupuncture
Intervention Type
Procedure
Intervention Name(s)
laser acupuncture
Other Intervention Name(s)
Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany
Intervention Description
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
Intervention Name(s)
placebo laser acupuncture
Other Intervention Name(s)
placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany
Intervention Description
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
Primary Outcome Measure Information:
Title
episodes of retching/vomiting per day during 1 chemotherapy course
Time Frame
1 chemotherapy course (5 days)
Secondary Outcome Measure Information:
Title
rescue antiemetic medication during 1 chemotherapy course
Time Frame
1 chemotherapy course (5 days)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Gottschling, MD
Phone
+49 6841 1628399
Email
kisgot@uniklinikum-saarland.de
First Name & Middle Initial & Last Name or Official Title & Degree
Norbert Graf, MD, PhD
Phone
+49 6841 1628397
Email
kingra@uniklinikum-saarland.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Gottschling, MD
Organizational Affiliation
University Children's Hospital Homburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Graf, MD, PhD
Organizational Affiliation
University Children's Hospital Homburg, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University Children's Hospital Tübingen
City
Tübingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Braun, MD
Phone
+ 49 07071 80894
Email
regibraun@gmx.de
First Name & Middle Initial & Last Name & Degree
Regina Braun, MD
Facility Name
University Children's Hospital Homburg
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Gottschling, MD
Phone
+49 6841 1628399
Email
kisgot@uniklinikum-saarland.de
First Name & Middle Initial & Last Name & Degree
Sven Gottschling, MD

12. IPD Sharing Statement

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Laser Acupuncture Against Nausea in Children

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