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

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Malignant Tumor
Chemotherapy-induced Nausea and Vomiting
Children

Treatments

Other: laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03354741
17-AOI-06

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

2 to 20 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Laser then Sham therapy
Other group
Description:
2nd cycle of chemotherapy : administration of laser therapy 3th cycle of chemotherapy : administration of a sham laser according to the same modalities
Treatment:
Other: laser therapy
Sham therapy then laser
Other group
Description:
2nd cycle of chemotherapy : administration of a sham laser 3th cycle of chemotherapy : administration of laser therapy according to the same modalities
Treatment:
Other: laser therapy

Trial contacts and locations

1

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Central trial contact

Marilyne POIREE, MD

Data sourced from clinicaltrials.gov

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