Laser Acupuncture Against Nausea in Children

NCT00528554 | Unknown

• 1 other identifier: SG-07-HT-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Conditions

Nausea; Vomiting; Cancer

Keywords

CINV; chemotherapy induced nausea and vomiting (CINV)

Outcome Measures

Primary Outcomes (1)

• episodes of retching/vomiting per day during 1 chemotherapy course

  1 chemotherapy course (5 days)

Secondary Outcomes (1)

• rescue antiemetic medication during 1 chemotherapy course

  1 chemotherapy course (5 days)

Study Arms (2)

A

ACTIVE COMPARATOR

Active laser acupuncture

Procedure: laser acupuncture

B

PLACEBO COMPARATOR

Placebo laser acupuncture

Procedure: placebo laser acupuncture

Interventions

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

Also known as: Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany

A

placebo laser acupuncture PROCEDURE

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

Also known as: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

B

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 0-17,
• Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)

You may not qualify if:

• Age older than 17 years,
• Participation in another clinical trial on supportive care

Sponsors & Collaborators

• University Children Hospital Homburg: lead
• University Hospital Tuebingen: collaborator

Study Sites (2)

University Children's Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

University Children's Hospital Homburg

Homburg, Saarland, 66421, Germany

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sven Gottschling, MD

  University Children's Hospital Homburg, Germany

  PRINCIPAL INVESTIGATOR

• Norbert Graf, MD, PhD

  University Children's Hospital Homburg, Germany

  STUDY DIRECTOR

Central Study Contacts

Sven Gottschling, MD

CONTACT

+49 6841 1628399; kisgot@uniklinikum-saarland.de

Norbert Graf, MD, PhD

CONTACT

+49 6841 1628397; kingra@uniklinikum-saarland.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: September 18, 2007

Record last verified: 2007-09

Locations

DE (2)