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

Children Clinical Trial

— NAUVOLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354741
• Other study ID #: 17-AOI-06
• Status: Completed
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: September 23, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 23, 2023
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Children
• Malignant Tumor
• Nausea
• Vomiting

Intervention

Other:
• laser therapy
stimulation of the acupuncture point P6 by laser therapy

Locations

Country	Name	City	State
France	Dr Marilyne POIREE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Hours 72 after the end of chemotherapy