Pediatric Cancer, Solid Tumor
Conditions
Keywords
cancer, children, diarrhea, acupuncture, irinotecan
Brief summary
To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted. Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximately one year.
Detailed description
Pre-post pilot study non-randomized, open label, single arm study. The objective of this pilot study is to demonstrate that cancer acupuncture pediatric treatment is a safe and feasible treatment in the prevention of late-onset diarrhea related to with irinotecan. This pilot study will include patients between 0 and 18 years of age with a solid tumor (nephroblastoma, neuroblastoma, central nervous system tumors and rhabdomyosarcoma) receiving their first cycle of irinotecan, in our center, at 50 mg/m2/intravenous dose daily for five days (cumulative dose weekly = 250 mg/m2) and who do not receive concomitant abdominal radiotherapy. Acupuncture will be applied as a complementary treatment along with the usual regimen of prophylaxis and treatment of late diarrhea.
Interventions
OTHERAcupuncture
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.
Sponsors
Fundació Sant Joan de Déu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pre-post feasibility
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during the intervention | 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. |
| Side effects | 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. |
| Degree of severity of diarrhea | 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 |
| Dose of antidiarrheal drugs | 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. |
| Prophylactic regimen of cefixime | Day 1 | Prophylactic regimen of cefixime before starting the cycle of irinotecan and the use of regimen prolonged 10 days. (Yes/No) |
| Abdominal pain treatment-related | Day 1 | Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result. |
| Satisfaction degree | Day 15 | Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments |
| Determination of the UGT1A1 polymorphism | 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). |
| Nausea | Day 1 | Record whether or not the patient has nausea (YES/NO) |
| Vomiting | Day 1 | Record whether or not the patient has vomiting (YES/NO) |
| Dose of antiemetic drugs (ondasentron) | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATOREsther Martinez, MD
Hospital Sant Joan de Deu
Outcome results
None listed