Pediatric CancerAIP2021NCT05507736
Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors
A study testing Acupuncture in people with Pediatric Cancer and Solid Tumor, run by Fundació Sant Joan de Déu at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Cancer, Solid Tumor
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Pediatric Cancer, Solid Tumor
- Being tested
- Acupuncture
- Keywords
- cancer, children, diarrhea, acupuncture, irinotecan
- Medical subject headings
- Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 5
Secondary outcomes (97)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Satisfaction degree
Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments
Measured: 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).
Measured: Day 1
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 1
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 2
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 3
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 4
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 5
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 6
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 7
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 8
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 9
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 10
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 11
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 12
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 13
Nausea
Record whether or not the patient has nausea (YES/NO)
Measured: Day 14
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 1
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 2
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 3
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 4
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 5
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 6
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 7
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 8
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 9
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 10
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 11
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 12
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: Day 13
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Oct 2022
- Primary completion28 Feb 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post feasibility
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Martinez, MD, Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507736
- Sponsor's protocol ID
- PS-20-21
- Acronym
- AIP2021
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05507736
- Acronym / sponsor ID
- AIP2021 / PS-20-21
- Conditions
- Pediatric Cancer, Solid Tumor
- Keywords
- cancer, children, diarrhea, acupuncture, irinotecan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post feasibility
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: AcupuncturePre-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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)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 | Experimental |
Primary outcome
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.
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.
97 secondary outcomes
Pain intensity during the intervention
Time frame: Day 1
Pain intensity during the intervention
Time frame: Day 2
Pain intensity during the intervention
Time frame: Day 3
Pain intensity during the intervention
Time frame: Day 4
Pain intensity during the intervention
Time frame: Day 5
Pain intensity during the intervention
Time frame: Day 6
Pain intensity during the intervention
Time frame: Day 7
Pain intensity during the intervention
Time frame: Day 8
Pain intensity during the intervention
Time frame: Day 9
Side effects
Time frame: Day 9
Degree of severity of diarrhea
Time frame: Day 1
Degree of severity of diarrhea
Time frame: Day 2
Degree of severity of diarrhea
Time frame: Day 3
Degree of severity of diarrhea
Time frame: Day 4
Degree of severity of diarrhea
Time frame: Day 5
Degree of severity of diarrhea
Time frame: Day 6
Degree of severity of diarrhea
Time frame: Day 7
Degree of severity of diarrhea
Time frame: Day 8
Degree of severity of diarrhea
Time frame: Day 9
Degree of severity of diarrhea
Time frame: Day 10
Degree of severity of diarrhea
Time frame: Day 11
Degree of severity of diarrhea
Time frame: Day 12
Degree of severity of diarrhea
Time frame: Day 13
Degree of severity of diarrhea
Time frame: Day 14
Dose of antidiarrheal drugs
Time frame: Day 1
Dose of antidiarrheal drugs
Time frame: Day 2
Dose of antidiarrheal drugs
Time frame: Day 3
Dose of antidiarrheal drugs
Time frame: Day 4
Dose of antidiarrheal drugs
Time frame: Day 5
Dose of antidiarrheal drugs
Time frame: Day 6
Dose of antidiarrheal drugs
Time frame: Day 7
Dose of antidiarrheal drugs
Time frame: Day 8
Dose of antidiarrheal drugs
Time frame: Day 9
Dose of antidiarrheal drugs
Time frame: Day 10
Dose of antidiarrheal drugs
Time frame: Day 11
Dose of antidiarrheal drugs
Time frame: Day 12
Dose of antidiarrheal drugs
Time frame: Day 13
Dose of antidiarrheal drugs
Time frame: Day 14
Prophylactic regimen of cefixime
Time frame: Day 1
Abdominal pain treatment-related
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Martinez, MD principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Pediatric Cancer and Solid Tumor, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during the procedure (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.