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

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ClinicalTrials.gov Identifier: NCT03354741
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

November 8, 2017
November 28, 2017
September 6, 2018
October 2018
March 2019   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT03354741 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Children
  • Chemotherapy-induced Nausea and Vomiting
  • Malignant Tumor
Other: laser therapy
stimulation of the acupuncture point P6 by laser therapy
  • 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
    Intervention: Other: 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
    Intervention: Other: laser therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Same as current
March 2020
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 20 Years   (Child, Adult)
No
Contact: Marilyne POIREE, MD 04 92 03 92 93 poiree.m@chu-nice.fr
France
 
 
NCT03354741
17-AOI-06
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Marilyne POIREE, MD CHU de Nice
Centre Hospitalier Universitaire de Nice
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP