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

This study is not yet open for participant recruitment.
Verified October 2017 by Centre Hospitalier Universitaire de Nice
Sponsor:
ClinicalTrials.gov Identifier:
NCT03354741
First Posted: November 28, 2017
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose

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.


Condition Intervention
Children Chemotherapy-induced Nausea and Vomiting Malignant Tumor Other: laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome 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).


Estimated Enrollment: 30
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354741


Contacts
Contact: Marilyne POIREE, MD 04 92 03 92 93 poiree.m@chu-nice.fr

Locations
France
Dr Marilyne POIREE Not yet recruiting
Nice, France
Contact: Marilyne Poiree, MD    04 92 03 92 93    poiree.m@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Marilyne POIREE, MD CHU de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03354741     History of Changes
Other Study ID Numbers: 17-AOI-06
First Submitted: November 8, 2017
First Posted: November 28, 2017
Last Update Posted: November 28, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nausea
Vomiting
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms