ChildrenNAUVOLANCT03354741
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
A study testing laser therapy in people with Children and Chemotherapy-induced Nausea and Vomiting, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor… Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Children, Chemotherapy-induced Nausea and Vomiting, Malignant Tumor
- What is being tested?
- laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2019to 23 Sep 2023
- 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 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential
- Indication of at least three identical chemotherapy cures
- Age between 2 and 20 years
- Prescription of an anti emetic protocol
- Karnosky / Lansky Index> 60%
Who cannot join
- Proven laser contraindication
- Vomiting in the 24 hours before starting treatment
- Presenting a brain lesion responsible for nausea and vomiting
- Pelvic abdominal irradiation the week before the start of treatment
- Treatment with benzodiazepines or opioids the week before treatment
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.
We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.
- Being tested
- laser therapy
- Medical subject headings
- Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyOther
stimulation of the acupuncture point P6 by laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Laser then Sham therapy | Other | 2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities Receives: Other: laser therapy |
| Sham therapy then laser | Other | 2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities Receives: Other: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response to the preventive treatment of nausea and vomiting
The complete response to the preventive treatment of nausea and vomiting defined by the absence of vomiting (active rejection by the mouth of part of the contents of the stomach), absence of nausea (effort of vomiting without active rejection) and the lack of emergency antiemetic treatment during the acute and delayed phase of chemotherapy (from the onset of chemotherapy to H72 after the end of chemotherapy).
Measured: Hours 72 after the end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start23 May 2019
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyne POIREE, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354741
- Sponsor's protocol ID
- 17-AOI-06
- Acronym
- NAUVOLA
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2017
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renaux Torres MC, Bouttefroy S, Letort-Bertrand M, Maurel V, Mouffak S, Scotte F, Slimano F, Treguier P, Dupuis LL, Poiree M, Thouvenin-Doulet S. [Chemotherapy-induced nausea and vomiting in pediatric oncology patients: 2023 recommendations from the Supportive Care Committee of the French Society of Cancer in Children and Adolescents]. Bull Cancer. 2024 Jun;111(6):608-619. doi: 10.1016/j.bulcan.2024.02.017. Epub 2024 Apr 25. French.
PubMed 38670821
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
- ClinicalTrials.gov ID
- NCT03354741
- Acronym / sponsor ID
- NAUVOLA / 17-AOI-06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 28 Nov 2017 (actual)
- 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.
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.
We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser then Sham therapy | Other | Other: laser therapy2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities |
| Sham therapy then laser | Other | Other: laser therapy2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential
- Indication of at least three identical chemotherapy cures
- Age between 2 and 20 years
- Prescription of an anti emetic protocol
- Karnosky / Lansky Index> 60%
Key exclusion criteria (6 listed)
- Proven laser contraindication
- Vomiting in the 24 hours before starting treatment
- Presenting a brain lesion responsible for nausea and vomiting
- Pelvic abdominal irradiation the week before the start of treatment
- Treatment with benzodiazepines or opioids the week before treatment
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 therapystimulation of the acupuncture point P6 by laser therapy | Other | Laser then Sham therapy, Sham therapy then laser |
Primary outcome
The complete response to the preventive treatment of nausea and vomiting
Time frame: Hours 72 after the end of chemotherapy
The complete response to the preventive treatment of nausea and vomiting defined by the absence of vomiting (active rejection by the mouth of part of the contents of the stomach), absence of nausea (effort of vomiting without active rejection) and the lack of emergency antiemetic treatment during the acute and delayed phase of chemotherapy (from the onset of chemotherapy to H72 after the end of chemotherapy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 38670821Renaux Torres MC, Bouttefroy S, Letort-Bertrand M, Maurel V, Mouffak S, Scotte F, Slimano F, Treguier P, Dupuis LL, Poiree M, Thouvenin-Doulet S. [Chemotherapy-induced nausea and vomiting in pediatric oncology patients: 2023 recommendations from the Supportive Care Committee of the French Society of Cancer in Children and Adolescents]. Bull Cancer. 2024 Jun;111(6):608-619. doi: 10.1016/j.bulcan.2024.02.017. Epub 2024 Apr 25. French.
- Individual participant dataSharing planned: No
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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.
Marilyne POIREE, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy in people with Children and Chemotherapy-induced Nausea and Vomiting, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete response to the preventive treatment of nausea and vomiting (time frame: Hours 72 after the end of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354741, which also lists 1 linked publication.
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 27 Mar 2026.