NauseaNCT00528554
Laser Acupuncture Against Nausea in Children
A study testing laser acupuncture in people with Nausea and Vomiting, run by University Children Hospital Homburg at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- What is being tested?
- laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-17,
- Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)
Who cannot join
- Age older than 17 years,
- Participation in another clinical trial on supportive care
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Children's Hospital Homburg
Homburg, Saarland, 66421
Sven Gottschling, MD, +49 6841 1628399, kisgot@uniklinikum-saarland.de
Sven Gottschling, MD
- Recruiting
University Children's Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Regina Braun, MD, + 49 07071 80894, regibraun@gmx.de
Regina Braun, MD
About this study
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
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
- Being tested
- laser acupuncture, placebo laser acupuncture
- Keywords
- CINV, chemotherapy induced nausea and vomiting (CINV)
- Medical subject headings
- Nausea, Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureProcedure or surgery
Also called Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germany
laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course
placebo laser acupunctureProcedure or surgery
Also called placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany
laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active laser acupuncture Receives: Procedure: laser acupuncture |
| B | Placebo comparator | Placebo laser acupuncture Receives: Procedure: placebo laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
episodes of retching/vomiting per day during 1 chemotherapy course
Measured: 1 chemotherapy course (5 days)
Secondary outcomes (1)
rescue antiemetic medication during 1 chemotherapy course
Measured: 1 chemotherapy course (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children Hospital Homburg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Investigators
- Sven Gottschling, MD, Principal investigator, University Children's Hospital Homburg, GermanyNorbert Graf, MD, PhD, Study director, University Children's Hospital Homburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528554
- Sponsor's protocol ID
- SG-07-HT-01
- Status last verified
- Sep 2007
- First submitted
- 11 Sep 2007
- Last updated
- 18 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00528554
- Acronym / sponsor ID
- SG-07-HT-01
- Keywords
- CINV, chemotherapy induced nausea and vomiting (CINV)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Children Hospital HomburgUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Sep 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: laser acupunctureActive laser acupuncture |
| B | Placebo comparator | Procedure: placebo laser acupuncturePlacebo laser acupuncture |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0-17,
- Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)
Key exclusion criteria (2 listed)
- Age older than 17 years,
- Participation in another clinical trial on supportive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser acupunctureAlso: Laser device: Modulas handy 2/99, 830 nm continuous wave, 30 mv 3,8 W/cm2, schwamedico, Ehringshausen, Germanylaser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course | Procedure or surgery | A |
| placebo laser acupunctureAlso: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germanylaser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course | Procedure or surgery | B |
Primary outcome
episodes of retching/vomiting per day during 1 chemotherapy course
Time frame: 1 chemotherapy course (5 days)
1 secondary outcome
rescue antiemetic medication during 1 chemotherapy course
Time frame: 1 chemotherapy course (5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Gottschling, MD principal investigator
University Children's Hospital Homburg, Germany
Norbert Graf, MD, PhD study director
University Children's Hospital Homburg, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Nausea and Vomiting, run by University Children Hospital Homburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Gottschling, MD (+49 6841 1628399, kisgot@uniklinikum-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
episodes of retching/vomiting per day during 1 chemotherapy course (time frame: 1 chemotherapy course (5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2007.