Clinical trial NCT05585463: Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Official title: Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pediatric
Neutropenia
Thrombocytopenia
Bacteremia
Infection;Skin;Localised
Safety Issues
Keywords: Acupuncture
Intracutaneous Needle
Cancer
Children
Neutropenia
Thrombocytopenia
Infection
Safety
Bacteremia
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 460
Sex: ALL
Minimum age (years): 1
Maximum age (years): 34
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with developmental cancer who have been treated with acupuncture and intracutaneous needles in the Integrative Pediatric Oncology Unit of the Sant Joan de Deu Hospital in Barcelona, Spain. Such patients include patients in active treatment and survivors.

Brief summary: This study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. For this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture and the use of intracutaneous needles in the patient in active treatment and survivor.

Detailed description: Retrospective study of review of medical records. It is a single-center, descriptive, observational study. There are no comparison or control groups. No type of patient selection (randomization or blinding) will be performed.

The medical records of patients treated at the Integrative Pediatric Oncology Unit from September 2019 to September 2021 who have received acupuncture treatment (disposable intracutaneous needles) will be reviewed.

The number of treatments applied, the localization of the treatment, the average number of sessions per patient, and the total number of intracutaneous needles and punctured needles from September 2019 to September 2021. Likewise, the blood cultures and other adverse effects will be reviewed up to 72 hours after the removal of the needles and the intracutaneous needles (Seirin New Pyonex Press Tack®).

Eligibility criteria: Inclusion Criteria:

* Pediatric oncology patients from September 2019 to September 2021 who have received treatment with acupuncture.
* Pediatric oncology patients from September 2019 to September 2021 who have received treatment with intracutaneous needles (Pyonex).

Exclusion Criteria:

* Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.

Primary outcomes:
measure: Incidence of local infection
timeFrame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
measure: Incidence of bacteremia
timeFrame: 72 hours after removal intracutaneous needle
Secondary outcomes:
measure: Incidence of bruising or bleeding
timeFrame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
measure: Incidence of sepsis
timeFrame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
measure: Incidence of skin erosion
timeFrame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
measure: Number of acupuncture needles
timeFrame: The day of the application of the acupuncture treatment
measure: Number of intracutaneous needles
timeFrame: The day of the application of the acupuncture treatment
measure: Degree of neutropenia
timeFrame: The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days
measure: Degree of thrombocytopenia
timeFrame: The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days
measure: Type of acupuncture treatment
timeFrame: The day of the application of the acupuncture treatment
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
Study officials:
affiliation: Fundació Sant Joan de Déu
name: Esther Martínez García, MD
role: PRINCIPAL_INVESTIGATOR
References: