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NCT Number: NCT05585463

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

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.

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Key information

Conditions

Cancer Pediatric Agranulocytosis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infection;Skin;Localised Infections Inflammation Leukocyte Disorders Leukopenia Neoplasms Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Safety Issues Sepsis Systemic Inflammatory Response Syndrome Thrombocytopenia

Age range

1 day–34 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

About this study

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®).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

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.

Primary outcomes

  1. Incidence of local infection

    Time frame: 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".

  2. Incidence of bacteremia

    Time frame: 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".

Secondary outcomes

  1. Incidence of bruising or bleeding

    Time frame: 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".

  2. Incidence of sepsis

    Time frame: 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".

  3. Incidence of skin erosion

    Time frame: 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".

  4. Number of acupuncture needles

    Time frame: 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.

  5. Number of intracutaneous needles

    Time frame: 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.

  6. Degree of neutropenia

    Time frame: 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

  7. Degree of thrombocytopenia

    Time frame: 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

  8. Type of acupuncture treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

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

Acronym: ACUSAFE2021

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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