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

NCT05507736 | Completed DMC

• 1 other identifier: PS-20-21
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Solid Tumor

Keywords

cancer; children; diarrhea; acupuncture; irinotecan

Outcome Measures

Primary Outcomes (2)

• Pain intensity during the procedure

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

  Day 1

• Pain intensity during the procedure

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

  Day 5

Secondary Outcomes (97)

• Pain intensity during the intervention

  Day 1

• Pain intensity during the intervention

  Day 2

• Pain intensity during the intervention

  Day 3

• Pain intensity during the intervention

  Day 4

• Pain intensity during the intervention

  Day 5

Study Arms (1)

Experimental

EXPERIMENTAL

Pre-Post feasibility treatment On the first cycle of irinotecan, the patient does not receive any intervention, we only collect data. This is the control cycle. There will be a single study group that will be used at the same time as your own control. On the second cycle of irinotecan, the patient receives acupuncture. There will be a single study group that will be used at the same time as your own control.

Other: Acupuncture

Interventions

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.

Also known as: Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)

Experimental

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Neoplasms; Diarrhea

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Esther Martinez, MD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post feasibility

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 19, 2022
• Study Start: October 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: August 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)