Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

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.

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Key information

Conditions

Children Chemotherapy-induced Nausea and Vomiting Malignant Tumor Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Marilyne POIREE

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%

Exclusion criteria

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

Treatment and study plan

LASER Therapy

Other

stimulation of the acupuncture point P6 by laser therapy

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: NAUVOLA

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Nov 28, 2017
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed