Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children (NAUVOLA)
Primary Purpose
Children, Chemotherapy-induced Nausea and Vomiting, Malignant Tumor
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
laser therapy
Sponsored by
About this trial
This is an interventional other trial for Children
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
Sites / Locations
- Dr Marilyne POIREE
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Laser then Sham therapy
Sham therapy then laser
Arm Description
2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities
2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03354741
First Posted
November 8, 2017
Last Updated
September 5, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03354741
Brief Title
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Acronym
NAUVOLA
Official Title
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Chemotherapy-induced Nausea and Vomiting, Malignant Tumor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser then Sham therapy
Arm Type
Other
Arm Description
2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities
Arm Title
Sham therapy then laser
Arm Type
Other
Arm Description
2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities
Intervention Type
Other
Intervention Name(s)
laser therapy
Intervention Description
stimulation of the acupuncture point P6 by laser therapy
Primary Outcome Measure Information:
Title
The complete response to the preventive treatment of nausea and vomiting
Description
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).
Time Frame
Hours 72 after the end of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyne POIREE, MD
Phone
04 92 03 92 93
Email
poiree.m@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyne POIREE, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Marilyne POIREE
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyne Poiree, MD
Phone
04 92 03 92 93
Email
poiree.m@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
We'll reach out to this number within 24 hrs