ClinicalTrials.Veeva

Menu

Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients (AIP2021)

F

Fundació Sant Joan de Déu

Status

Completed

Conditions

Solid Tumor
Pediatric Cancer

Treatments

Other: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT05507736
PS-20-21

Details and patient eligibility

About

To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted.

Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximately one year.

Full description

Pre-post pilot study non-randomized, open label, single arm study.

The objective of this pilot study is to demonstrate that cancer acupuncture pediatric treatment is a safe and feasible treatment in the prevention of late-onset diarrhea related to with irinotecan.

This pilot study will include patients between 0 and 18 years of age with a solid tumor (nephroblastoma, neuroblastoma, central nervous system tumors and rhabdomyosarcoma) receiving their first cycle of irinotecan, in our center, at 50 mg/m2/intravenous dose daily for five days (cumulative dose weekly = 250 mg/m2) and who do not receive concomitant abdominal radiotherapy. Acupuncture will be applied as a complementary treatment along with the usual regimen of prophylaxis and treatment of late diarrhea.

Enrollment

22 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.
  • Signature of informed consent by parents in the case of children under 12 years of age and assent of the minor.
  • Signature of informed consent in the case of those over 12 years of age

Exclusion criteria

  • Participate in a clinical trial that is developed in the Pediatric Oncology Area of the Hospital Sant Joan de Deu where acupuncture intervention is not permitted.
  • Have received acupuncture treatment in the last ten days.
  • Receive concomitant abdominal radiotherapy.
  • Have diarrhea on day 1 of the cycle

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Experimental
Experimental group
Description:
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.
Treatment:
Other: Acupuncture

Trial contacts and locations

1

Loading...

Central trial contact

Esther Martinez, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems