NCT05585463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

October 12, 2022

Last Update Submit

October 18, 2022

Conditions

Cancer PediatricNeutropeniaThrombocytopeniaBacteremiaInfection;Skin;LocalisedSafety Issues

Keywords

AcupunctureIntracutaneous NeedleCancerChildrenNeutropeniaThrombocytopeniaInfectionSafetyBacteremia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Incidence of bruising or bleeding

    From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)

  • Incidence of sepsis

    From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)

  • Incidence of skin erosion

    From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)

  • Number of acupuncture needles

    The day of the application of the acupuncture treatment

  • Number of intracutaneous needles

    The day of the application of the acupuncture treatment

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

acupuncturePROCEDURE

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.

Oncology pediatric patients treated with acupuncture

Eligibility Criteria

Age1 Day - 34 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

NeoplasmsNeutropeniaThrombocytopeniaBacteremiaInfections

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBlood Platelet DisordersBacterial InfectionsBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Esther Martínez García, MD

    Fundació Sant Joan de Déu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of integrative pediatric oncology. Pediatric Cancer Center Barcelona, Hospital Sant Joan de Deu

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 18, 2022

Study Start

September 1, 2019

Primary Completion

September 30, 2021

Study Completion

October 31, 2021

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

ES(1)