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

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 Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting; Children; Malignant Tumor
• Intervention / Treatment: Other: laser therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyne Poiree, MD; Phone Number: 04 92 03 92 93; Email: poiree.m@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Dr Marilyne POIREE
    • Contact: Marilyne Poiree, MD; Phone Number: 04 92 03 92 93; Email: poiree.m@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laser then Sham therapy; 2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities	Other: laser therapy; stimulation of the acupuncture point P6 by laser therapy
Other: Sham therapy then laser; 2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities	Other: laser therapy; stimulation of the acupuncture point P6 by laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Marilyne POIREE, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): September 23, 2023
• Study Completion (Actual): September 23, 2023

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 17-AOI-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No