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Completed
NCT05507736
Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors
Conditions: Pediatric Cancer, Solid Tumor
Sex: All
Ages: 0 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 22
Sponsor: Fundació Sant Joan de Déu
Location: Hospital Sant Joan de Deu Esplugues de Llobregat Barcelona
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05507736). StuddyBuddy aggregates publicly available trial information.