Cancer PediatricACUSAFE2021NCT05585463
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
An observational study of Cancer Pediatric and Neutropenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 1 day to 34 years
- Conditions the study is for
- Cancer Pediatric, Neutropenia, Thrombocytopenia
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 34 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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®).
- Conditions
- Cancer Pediatric, Neutropenia, Thrombocytopenia, Bacteremia, Infection;Skin;Localised, Safety Issues
- Being tested
- acupuncture
- Keywords
- Acupuncture, Intracutaneous Needle, Cancer, Children, Neutropenia, Thrombocytopenia, Infection, Safety, Bacteremia
- Medical subject headings
- Neoplasms, Neutropenia, Thrombocytopenia, Bacteremia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 72 hours after removal intracutaneous needle
Secondary outcomes (8)
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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: The day of the application of the acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Sep 2019
- Primary completion30 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Martinez Garcia, Fundació Sant Joan de Déu
- Investigators
- Esther Martínez García, MD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585463
- Sponsor's protocol ID
- PS-14-22
- Acronym
- ACUSAFE2021
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez Garcia E, Jordan I, Nishishinya Aquino MB, Lopez de San Roman Fernandez C, Perez-Jaume S, Morales-La Madrid A, Fernandez-Jane C, Cruz Martinez O. Safety of Acupuncture Using Semi-Permanent Needles in a Pediatric Cancer Unit: A Retrospective Study. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439141. doi: 10.1177/15347354261439141. Epub 2026 May 19.
PubMed 42152774
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05585463
- Acronym / sponsor ID
- ACUSAFE2021 / PS-14-22
- Conditions
- Cancer Pediatric, Neutropenia, Thrombocytopenia, Bacteremia, Infection;Skin;Localised, Safety Issues
- Keywords
- Acupuncture, Intracutaneous Needle, Cancer, Children, Neutropenia, Thrombocytopenia, Infection, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncology pediatric patients treated with acupuncture | – | Procedure: acupuncturePatients 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. |
Who may qualify
- Ages
- 1 day to 34 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture 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. | Procedure or surgery | Oncology pediatric patients treated with acupuncture |
Primary outcome
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".
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".
8 secondary outcomes
Incidence of bruising or bleeding
Time frame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Incidence of sepsis
Time frame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Incidence of skin erosion
Time frame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
Number of acupuncture needles
Time frame: The day of the application of the acupuncture treatment
Number of intracutaneous needles
Time frame: The day of the application of the acupuncture treatment
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
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
Type of acupuncture treatment
Time frame: The day of the application of the acupuncture treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 42152774Martinez Garcia E, Jordan I, Nishishinya Aquino MB, Lopez de San Roman Fernandez C, Perez-Jaume S, Morales-La Madrid A, Fernandez-Jane C, Cruz Martinez O. Safety of Acupuncture Using Semi-Permanent Needles in a Pediatric Cancer Unit: A Retrospective Study. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439141. doi: 10.1177/15347354261439141. Epub 2026 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Martínez García, MD principal investigator
Fundació Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pediatric and Neutropenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of local infection (time frame: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.