Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)

Completed

• Conditions: Cancer Pediatric; Neutropenia; Bacteremia; Infection;Skin;Localised; Safety Issues; Thrombocytopenia
• Interventions: Procedure: acupuncture

• Registration Number: NCT05585463
• Lead Sponsor: Fundació Sant Joan de Déu

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®).

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-18
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oncology pediatric patients treated with acupuncture	acupuncture	Patients in the oncology area of the Sant Joan de Déu Hospital treated at the UOPI (Integrative Pediatric Oncology Unit) from September 2019 to September 2021 have received treatment with acupuncture and intracutaneous Seirin New Pyonex Press Tack®. Patients in active treatment and survivors are included. Acupuncture treatment can be received in a hospitalization ward, an intensive care unit, a day hospital or an outpatient clinic.

Primary Outcome Measures

Name	Time	Method
Incidence of bacteremia	72 hours after removal intracutaneous needle	Analyze the incidence of positive blood cultures for gram-positive cocci up to 72 hours after removal of the intracutaneous Seirin New Pyonex Press Tack® needles.; The result can be "yes" or "no".
Incidence of local infection	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)	To calculate the incidence of local infection in pediatric oncology patients during the days that the intracutaneous Seirin New Pyonex Press Tack® needles have been inserted.; The result can be "yes" or "no".

Secondary Outcome Measures

Name	Time	Method
Incidence of skin erosion	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)	Identify other skin erosion related to acupuncture and its related techniques. The result can be "yes" or "no".
Type of acupuncture treatment	The day of the application of the acupuncture treatment	• Report whether the applied treatment has been auricular (insertion of Seirin New Pyonex Press Tack® in the auricular pavilion), corporal or mixed (both techniques are performed).; This data is recorded in all acupuncture interventions and can be consulted in the clinical history.
Incidence of bruising or bleeding	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)	To calculate the incidence of bruising or bleeding in pediatric oncology patients during the days that the intracutaneous Seirin New Pyonex Press Tack® needles have been inserted.; The result can be "yes" or "no".
Incidence of sepsis	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)	To analyze the incidence of sepsis due to gram-positive cocci up to 72 hours after the removal of the intracutaneous Seirin New Pyonex Press Tack® needles.; The result can be "yes" or "no".
Number of acupuncture needles	The day of the application of the acupuncture treatment	Count the number of needles inserted on the day of the event (treatment The result is a minimum of one needle. This data is recorded in all acupuncture interventions and can be consulted in the clinical history.
Number of intracutaneous needles	The day of the application of the acupuncture treatment	Count the number of intracutaneous needles inserted on the day of the event (treatment The result is a minimum of one needle. This data is recorded in all acupuncture interventions and can be consulted in the clinical history.
Degree of neutropenia	The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days	Report the patient's absolute neutrophil count and degree of neutropenia on the day of receiving acupuncture treatment (needles and/or Seirin New Pyonex Press Tack®).; The Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials, and other oncology settings will be used. The lowest degree is 1 and the maximum is 5
Degree of thrombocytopenia	The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days	Report the patient's absolute platelets count and degree of thrombocytopenia on the day receiving acupuncture treatment (needles and/or Seirin New Pyonex Press Tack®).; The Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings will be used. The lowest degree is 1 and the maximum, 5

Trial Locations

Locations (1)

Hospital Sant Joan de Deu; 🇪🇸 Esplugues De Llobregat, Barcelona, Spain