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

NCT ID: NCT03354741

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2023-09-23

Brief 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.

Conditions

Children; Chemotherapy-induced Nausea and Vomiting; Malignant Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

laser therapy

Intervention Type: OTHER

stimulation of the acupuncture point P6 by laser therapy

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

Group Type: OTHER

laser therapy

Intervention Type: OTHER

stimulation of the acupuncture point P6 by laser therapy

Interventions

laser therapy

stimulation of the acupuncture point P6 by laser therapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilyne POIREE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Dr Marilyne POIREE

Nice, , France

Countries

France

Other Identifiers

17-AOI-06

Identifier Type: -

Identifier Source: org_study_id