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

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)

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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