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

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombocytopenia; Neutropenia; Bacteremia; Safety Issues; Cancer Pediatric; Infection;Skin;Localised
• Intervention / Treatment: Procedure: acupuncture

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 Type: Observational
• Enrollment (Actual): 460

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Esplugues De Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 34 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Oncology pediatric patients treated with 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.

Procedure: acupuncture; Acupuncture with needles and intracutaneous needles in the ear or body. The insertion is done with gloves, a guide to puncture the needle, and exhaustive skin disinfection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of local infection	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".	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Incidence of bacteremia	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".	72 hours after removal intracutaneous needle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bruising or bleeding	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".	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Incidence of sepsis	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".	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Incidence of skin erosion	Identify other skin erosion related to acupuncture and its related techniques. The result can be "yes" or "no".	From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Number of acupuncture needles	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.	The day of the application of the acupuncture treatment
Number of intracutaneous needles	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.	The day of the application of the acupuncture treatment
Degree of neutropenia	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	The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days
Degree of thrombocytopenia	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	The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days
Type of 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.	The day of the application of the acupuncture treatment

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Investigators: Principal Investigator: Esther Martínez García, MD, Fundació Sant Joan de Déu

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Infection; Cancer; Acupuncture; Bacteremia; Children; Neutropenia; Thrombocytopenia; Intracutaneous Needle
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Blood Platelet Disorders; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Bacteremia; Thrombocytopenia
• Other Study ID Numbers: PS-14-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No