Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinoteca… (NCT05507736) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors
Spain22 participantsStarted 2022-10-01
Plain-language 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.
Who can participate
Age range
0 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.