Clinical trial NCT05507736: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Solid Tumor
Keywords: cancer
children
diarrhea
acupuncture
irinotecan
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 22
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post feasibility
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain intensity during the procedure
timeFrame: Day 1
measure: Pain intensity during the procedure
timeFrame: Day 5
Secondary outcomes:
measure: Pain intensity during the intervention
timeFrame: Day 1
measure: Pain intensity during the intervention
timeFrame: Day 2
measure: Pain intensity during the intervention
timeFrame: Day 3
measure: Pain intensity during the intervention
timeFrame: Day 4
measure: Pain intensity during the intervention
timeFrame: Day 5
measure: Pain intensity during the intervention
timeFrame: Day 6
measure: Pain intensity during the intervention
timeFrame: Day 7
measure: Pain intensity during the intervention
timeFrame: Day 8
measure: Pain intensity during the intervention
timeFrame: Day 9
measure: Side effects
timeFrame: Day 9
measure: Degree of severity of diarrhea
timeFrame: Day 1
measure: Degree of severity of diarrhea
timeFrame: Day 2
measure: Degree of severity of diarrhea
timeFrame: Day 3
measure: Degree of severity of diarrhea
timeFrame: Day 4
measure: Degree of severity of diarrhea
timeFrame: Day 5
measure: Degree of severity of diarrhea
timeFrame: Day 6
measure: Degree of severity of diarrhea
timeFrame: Day 7
measure: Degree of severity of diarrhea
timeFrame: Day 8
measure: Degree of severity of diarrhea
timeFrame: Day 9
measure: Degree of severity of diarrhea
timeFrame: Day 10
measure: Degree of severity of diarrhea
timeFrame: Day 11
measure: Degree of severity of diarrhea
timeFrame: Day 12
measure: Degree of severity of diarrhea
timeFrame: Day 13
measure: Degree of severity of diarrhea
timeFrame: Day 14
measure: Dose of antidiarrheal drugs
timeFrame: Day 1
measure: Dose of antidiarrheal drugs
timeFrame: Day 2
measure: Dose of antidiarrheal drugs
timeFrame: Day 3
measure: Dose of antidiarrheal drugs
timeFrame: Day 4
measure: Dose of antidiarrheal drugs
timeFrame: Day 5
measure: Dose of antidiarrheal drugs
timeFrame: Day 6
measure: Dose of antidiarrheal drugs
timeFrame: Day 7
measure: Dose of antidiarrheal drugs
timeFrame: Day 8
measure: Dose of antidiarrheal drugs
timeFrame: Day 9
measure: Dose of antidiarrheal drugs
timeFrame: Day 10
measure: Dose of antidiarrheal drugs
timeFrame: Day 11
measure: Dose of antidiarrheal drugs
timeFrame: Day 12
measure: Dose of antidiarrheal drugs
timeFrame: Day 13
measure: Dose of antidiarrheal drugs
timeFrame: Day 14
measure: Prophylactic regimen of cefixime
timeFrame: Day 1
measure: Abdominal pain treatment-related
timeFrame: Day 1
measure: Abdominal pain treatment-related
timeFrame: Day 2
measure: Abdominal pain treatment-related
timeFrame: Day 3
measure: Abdominal pain treatment-related
timeFrame: Day 4
measure: Abdominal pain treatment-related
timeFrame: Day 5
measure: Abdominal pain treatment-related
timeFrame: Day 6
measure: Abdominal pain treatment-related
timeFrame: Day 7
measure: Abdominal pain treatment-related
timeFrame: Day 8
measure: Abdominal pain treatment-related
timeFrame: Day 9
measure: Abdominal pain treatment-related
timeFrame: Day 10
measure: Abdominal pain treatment-related
timeFrame: Day 11
measure: Abdominal pain treatment-related
timeFrame: Day 12
measure: Abdominal pain treatment-related
timeFrame: Day 13
measure: Abdominal pain treatment-related
timeFrame: Day 14
measure: Satisfaction degree
timeFrame: Day 15
measure: Determination of the UGT1A1 polymorphism
timeFrame: Day 1
measure: Nausea
timeFrame: Day 1
measure: Nausea
timeFrame: Day 2
measure: Nausea
timeFrame: Day 3
measure: Nausea
timeFrame: Day 4
measure: Nausea
timeFrame: Day 5
measure: Nausea
timeFrame: Day 6
measure: Nausea
timeFrame: Day 7
measure: Nausea
timeFrame: Day 8
measure: Nausea
timeFrame: Day 9
measure: Nausea
timeFrame: Day 10
measure: Nausea
timeFrame: Day 11
measure: Nausea
timeFrame: Day 12
measure: Nausea
timeFrame: Day 13
measure: Nausea
timeFrame: Day 14
measure: Vomiting
timeFrame: Day 1
measure: Vomiting
timeFrame: Day 2
measure: Vomiting
timeFrame: Day 3
measure: Vomiting
timeFrame: Day 4
measure: Vomiting
timeFrame: Day 5
measure: Vomiting
timeFrame: Day 6
measure: Vomiting
timeFrame: Day 7
measure: Vomiting
timeFrame: Day 8
measure: Vomiting
timeFrame: Day 9
measure: Vomiting
timeFrame: Day 10
measure: Vomiting
timeFrame: Day 11
measure: Vomiting
timeFrame: Day 12
measure: Vomiting
timeFrame: Day 13
measure: Vomiting
timeFrame: Day 14
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 1
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 2
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 3
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 4
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 5
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 6
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 7
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 8
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 9
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 10
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 11
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 12
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 13
measure: Dose of antiemetic drugs (ondasentron)
timeFrame: Day 14
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
Study officials:
affiliation: Hospital Sant Joan de Deu
name: Esther Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: