NCT05507736

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

Feasibility and Safety of the Use of Acupuncture in the Prevention of Late-onset Diarrhea Associated With Irinotecan in Pediatric Patients With Solid Tumors: Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pediatric Cancer
• Solid Tumor

Interventions

Type	Name	Description
OTHER	Acupuncture	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-02-28
• Completion: 2024-08-01
• First posted: 2022-08-19
• Last updated: 2024-08-13

Locations

1 site across 1 country: Spain