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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 23, 2023

Interventions

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

Arms, Groups and Cohorts

  • 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: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marilyne POIREE, MD, Principal Investigator, Centre Hospitalier Universitaire de Nice

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.