Skip to main content
OpenTrials
Completed

NCT Number: NCT05507736

Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric Cancer Diarrhea Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Solid Tumor

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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®)

Primary outcomes

  1. Pain intensity during the procedure

    Time frame: Day 1

    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.

  2. Pain intensity during the procedure

    Time frame: Day 5

    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.

Secondary outcomes

  1. Pain intensity during the intervention

    Time frame: Day 1

    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.

  2. Pain intensity during the intervention

    Time frame: Day 2

    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.

  3. Pain intensity during the intervention

    Time frame: Day 3

    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.

  4. Pain intensity during the intervention

    Time frame: Day 4

    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.

  5. Pain intensity during the intervention

    Time frame: Day 5

    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.

  6. Pain intensity during the intervention

    Time frame: Day 6

    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.

  7. Pain intensity during the intervention

    Time frame: Day 7

    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.

  8. Pain intensity during the intervention

    Time frame: Day 8

    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.

  9. Pain intensity during the intervention

    Time frame: Day 9

    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.

  10. Side effects

    Time frame: Day 9

    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.

  11. Degree of severity of diarrhea

    Time frame: Day 1

    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

  12. Degree of severity of diarrhea

    Time frame: Day 2

    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

  13. Degree of severity of diarrhea

    Time frame: Day 3

    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

  14. Degree of severity of diarrhea

    Time frame: Day 4

    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

  15. Degree of severity of diarrhea

    Time frame: Day 5

    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

  16. Degree of severity of diarrhea

    Time frame: Day 6

    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

  17. Degree of severity of diarrhea

    Time frame: Day 7

    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

  18. Degree of severity of diarrhea

    Time frame: Day 8

    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

  19. Degree of severity of diarrhea

    Time frame: Day 9

    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

  20. Degree of severity of diarrhea

    Time frame: Day 10

    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

  21. Degree of severity of diarrhea

    Time frame: Day 11

    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

  22. Degree of severity of diarrhea

    Time frame: Day 12

    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

  23. Degree of severity of diarrhea

    Time frame: Day 13

    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

  24. Degree of severity of diarrhea

    Time frame: Day 14

    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

  25. Dose of antidiarrheal drugs

    Time frame: Day 1

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  26. Dose of antidiarrheal drugs

    Time frame: Day 2

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  27. Dose of antidiarrheal drugs

    Time frame: Day 3

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  28. Dose of antidiarrheal drugs

    Time frame: Day 4

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  29. Dose of antidiarrheal drugs

    Time frame: Day 5

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  30. Dose of antidiarrheal drugs

    Time frame: Day 6

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  31. Dose of antidiarrheal drugs

    Time frame: Day 7

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  32. Dose of antidiarrheal drugs

    Time frame: Day 8

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  33. Dose of antidiarrheal drugs

    Time frame: Day 9

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  34. Dose of antidiarrheal drugs

    Time frame: Day 10

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  35. Dose of antidiarrheal drugs

    Time frame: Day 11

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  36. Dose of antidiarrheal drugs

    Time frame: Day 12

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  37. Dose of antidiarrheal drugs

    Time frame: Day 13

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  38. Dose of antidiarrheal drugs

    Time frame: Day 14

    Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  39. Prophylactic regimen of cefixime

    Time frame: Day 1

    Prophylactic regimen of cefixime before starting the cycle of irinotecan and the use of regimen prolonged 10 days. (Yes/No)

  40. Abdominal pain treatment-related

    Time frame: Day 1

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  41. Abdominal pain treatment-related

    Time frame: Day 2

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  42. Abdominal pain treatment-related

    Time frame: Day 3

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  43. Abdominal pain treatment-related

    Time frame: Day 4

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  44. Abdominal pain treatment-related

    Time frame: Day 5

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  45. Abdominal pain treatment-related

    Time frame: Day 6

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  46. Abdominal pain treatment-related

    Time frame: Day 7

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  47. Abdominal pain treatment-related

    Time frame: Day 8

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  48. Abdominal pain treatment-related

    Time frame: Day 9

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  49. Abdominal pain treatment-related

    Time frame: Day 10

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  50. Abdominal pain treatment-related

    Time frame: Day 11

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  51. Abdominal pain treatment-related

    Time frame: Day 12

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  52. Abdominal pain treatment-related

    Time frame: Day 13

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  53. Abdominal pain treatment-related

    Time frame: Day 14

    Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.

  54. Satisfaction degree

    Time frame: Day 15

    Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments

  55. Determination of the UGT1A1 polymorphism

    Time frame: Day 1

    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).

  56. Nausea

    Time frame: Day 1

    Record whether or not the patient has nausea (YES/NO)

  57. Nausea

    Time frame: Day 2

    Record whether or not the patient has nausea (YES/NO)

  58. Nausea

    Time frame: Day 3

    Record whether or not the patient has nausea (YES/NO)

  59. Nausea

    Time frame: Day 4

    Record whether or not the patient has nausea (YES/NO)

  60. Nausea

    Time frame: Day 5

    Record whether or not the patient has nausea (YES/NO)

  61. Nausea

    Time frame: Day 6

    Record whether or not the patient has nausea (YES/NO)

  62. Nausea

    Time frame: Day 7

    Record whether or not the patient has nausea (YES/NO)

  63. Nausea

    Time frame: Day 8

    Record whether or not the patient has nausea (YES/NO)

  64. Nausea

    Time frame: Day 9

    Record whether or not the patient has nausea (YES/NO)

  65. Nausea

    Time frame: Day 10

    Record whether or not the patient has nausea (YES/NO)

  66. Nausea

    Time frame: Day 11

    Record whether or not the patient has nausea (YES/NO)

  67. Nausea

    Time frame: Day 12

    Record whether or not the patient has nausea (YES/NO)

  68. Nausea

    Time frame: Day 13

    Record whether or not the patient has nausea (YES/NO)

  69. Nausea

    Time frame: Day 14

    Record whether or not the patient has nausea (YES/NO)

  70. Vomiting

    Time frame: Day 1

    Record whether or not the patient has vomiting (YES/NO)

  71. Vomiting

    Time frame: Day 2

    Record whether or not the patient has vomiting (YES/NO)

  72. Vomiting

    Time frame: Day 3

    Record whether or not the patient has vomiting (YES/NO)

  73. Vomiting

    Time frame: Day 4

    Record whether or not the patient has vomiting (YES/NO)

  74. Vomiting

    Time frame: Day 5

    Record whether or not the patient has vomiting (YES/NO)

  75. Vomiting

    Time frame: Day 6

    Record whether or not the patient has vomiting (YES/NO)

  76. Vomiting

    Time frame: Day 7

    Record whether or not the patient has vomiting (YES/NO)

  77. Vomiting

    Time frame: Day 8

    Record whether or not the patient has vomiting (YES/NO)

  78. Vomiting

    Time frame: Day 9

    Record whether or not the patient has vomiting (YES/NO)

  79. Vomiting

    Time frame: Day 10

    Record whether or not the patient has vomiting (YES/NO)

  80. Vomiting

    Time frame: Day 11

    Record whether or not the patient has vomiting (YES/NO)

  81. Vomiting

    Time frame: Day 12

    Record whether or not the patient has vomiting (YES/NO)

  82. Vomiting

    Time frame: Day 13

    Record whether or not the patient has vomiting (YES/NO)

  83. Vomiting

    Time frame: Day 14

    Record whether or not the patient has vomiting (YES/NO)

  84. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 1

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  85. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 2

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  86. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 3

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  87. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 4

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  88. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 5

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  89. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 6

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  90. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 7

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  91. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 8

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  92. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 9

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  93. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 10

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  94. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 11

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  95. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 12

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  96. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 13

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

  97. Dose of antiemetic drugs (ondasentron)

    Time frame: Day 14

    Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors: A Prospective Pilot Study

Acronym: AIP2021

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 19, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.