Trials Sponsors Conditions Drugs Pricing

Conditions

Pediatric Cancer Solid Tumor

Keywords

cancerchildrendiarrheaacupunctureirinotecan

Outcome Measures

Primary Outcomes (2)

Pain intensity during the procedure
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (\<3 years), Wong-Baker scale of faces for cooperative children (0-10) (\>3 years) and numerical scale (0-10) for collaborating children (\>6 years). Higher scores mean a worse result.
Day 1
Pain intensity during the procedure
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (\<3 years), Wong-Baker scale of faces for cooperative children (0-10) (\>3 years) and numerical scale (0-10) for collaborating children (\>6 years). Higher scores mean a worse result.
Day 5

Secondary Outcomes (97)

Pain intensity during the intervention
Day 1
Pain intensity during the intervention
Day 2
Pain intensity during the intervention
Day 3
Pain intensity during the intervention
Day 4
Pain intensity during the intervention
Day 5
+92 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

Pre-Post feasibility treatment On the first cycle of irinotecan, the patient does not receive any intervention, we only collect data. This is the control cycle. There will be a single study group that will be used at the same time as your own control. On the second cycle of irinotecan, the patient receives acupuncture. There will be a single study group that will be used at the same time as your own control.

Other: Acupuncture

Interventions

AcupunctureOther

13 Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX® from 0.9 mm in length and 0.22 mm in diameter) on day 1 and 5 of the second cycle of irinotecan leaving them inserted for 4 days.

Also known as: Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)

Experimental

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age0 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Patients from 0 to 18 years old with solid tumors who start treatment in our center with irinotecan at 50 mg/m2/intravenous dose in day hospital.
Blood tests prior to the start of the appropriate chemotherapy cycle to receive acupuncture with continuous stimulation needle insertion: neutrophils greater or equal to 1000 cells/mm3 and platelets greater than or equal to 50,000 cells/mm3.

Sponsors & Collaborators

Fundació Sant Joan de Déu
Otherlead

Study Sites (1)

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

MeSH Terms

Conditions

NeoplasmsDiarrhea

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

Esther Martinez, MD
Hospital Sant Joan de Deu
PRINCIPAL INVESTIGATOR

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

August 19, 2022

Study Start

October 1, 2022

Actual (reported)

Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (97)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (97)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations