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

Solid Tumor Clinical Trial

— AIP2021  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507736
• Other study ID #: PS-20-21
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Fundació Sant Joan de Déu
• Contact: Esther Martinez, MD
• Phone: +34 932532100
• Email: esther.martinez[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Pediatric Cancer
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Esplugues De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction degree	Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments	Day 15
Secondary	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
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 1
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 2
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 3
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 4
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 5
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 6
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 7
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 8
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 9
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 10
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 11
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 12
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 13
Secondary	Nausea	Record whether or not the patient has nausea (YES/NO)	Day 14
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 1
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 2
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 3
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 4
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 5
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 6
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 7
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 8
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 9
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 10
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 11
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 12
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 13
Secondary	Vomiting	Record whether or not the patient has vomiting (YES/NO)	Day 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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