Spots Global Cancer Trial Database for Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: 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

Study ID: NCT05507736

Conditions

Pediatric Cancer

Solid Tumor

Interventions

Acupuncture

Study Description

Brief 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.