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

Safety Issues Clinical Trial

— ACUSAFE2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585463
• Other study ID #: PS-14-22
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2022
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 31, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 1 Day to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Cancer Pediatric
• Neutropenia
• Safety Issues
• Thrombocytopenia

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Esplugues De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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