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

NCT03354741 | Completed

• 1 other identifier: 17-AOI-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Laser then Sham therapy

OTHER

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

Sham therapy then laser

OTHER

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

Interventions

laser therapy OTHER

stimulation of the acupuncture point P6 by laser therapy

Laser then Sham therapy; Sham therapy then laser

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Dr Marilyne POIREE

Nice, France

Location

Related Publications (1)

• Renaux Torres MC, Bouttefroy S, Letort-Bertrand M, Maurel V, Mouffak S, Scotte F, Slimano F, Treguier P, Dupuis LL, Poiree M, Thouvenin-Doulet S. [Chemotherapy-induced nausea and vomiting in pediatric oncology patients: 2023 recommendations from the Supportive Care Committee of the French Society of Cancer in Children and Adolescents]. Bull Cancer. 2024 Jun;111(6):608-619. doi: 10.1016/j.bulcan.2024.02.017. Epub 2024 Apr 25. French.

  PMID: 38670821 RESULT

MeSH Terms

Conditions

Vomiting; Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Marilyne POIREE, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 28, 2017
• Study Start: May 23, 2019
• Primary Completion: September 23, 2023
• Study Completion: September 23, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)