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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Pediatric Cancer
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Martinez, MD; Phone Number: 80524 +34 932532100; Email: esther.martinez@sjd.es

Study Locations

• Spain
  • Barcelona
    • Esplugues De Llobregat, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Déu
      • Contact: Esther Martinez, MD; Phone Number: 80524 +34 9.2532100; Email: esther.martinez@sjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; 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.

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.; Other Names: Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity during the procedure	Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 1
Pain intensity during the procedure	Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 1
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 2
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 3
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 4
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 5
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 6
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 7
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 8
Pain intensity during the intervention	Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.	Day 9
Side effects	Registry of other local adverse effects of acupuncture. will be delivered families recorded some items on day 9 of the second cycle (intervention cycle): local infection, hematoma, and skin damage.	Day 9
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 1
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 2
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 3
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 4
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 5
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 6
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 7
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 8
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 9
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 10
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 11
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 12
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 13
Degree of severity of diarrhea	Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death	Day 14
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 1
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 2
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 3
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 4
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 5
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 6
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 7
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 8
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 9
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 10
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 11
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 12
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 13
Dose of antidiarrheal drugs	Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 14
Prophylactic regimen of cefixime	Prophylactic regimen of cefixime before starting the cycle of irinotecan and the use of regimen prolonged 10 days. (Yes/No)	Day 1
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 1
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 2
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 3
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 4
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 5
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 6
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 7
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 8
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 9
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 10
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 11
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 12
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 13
Abdominal pain treatment-related	Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.	Day 14
Satisfaction degree	Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments	Day 15
Determination of the UGT1A1 polymorphism	Determination of the UGT1A1 polymorphism by blood sample in the analysis of routine performed on day 1 of the first cycle of irinotecan (control cycle).	Day 1
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 1
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 2
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 3
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 4
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 5
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 6
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 7
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 8
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 9
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 10
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 11
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 12
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 13
Nausea	Record whether or not the patient has nausea (YES/NO)	Day 14
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 1
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 2
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 3
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 4
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 5
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 6
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 7
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 8
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 9
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 10
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 11
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 12
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 13
Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 14
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 1
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 2
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 3
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 4
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 5
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 6
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 7
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 8
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 9
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 10
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 11
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 12
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 13
Dose of antiemetic drugs (ondasentron)	Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.	Day 14

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Investigators: Principal Investigator: Esther Martinez, MD, Hospital Sant Joan de Déu

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: cancer; children; diarrhea; acupuncture; irinotecan
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: PS-20-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No