Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors
NCT05507736
Diarrhea, Neoplasms
Esplugues de Llobregat, Barcelona, Spain
View Trial DetailsNCT Number: NCT07053579
The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients.
Participants provided demographic and clinical characteristics, and complete the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.
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Notify Me6 year–18 year
All sexes
Observational
Ka Yan Ho, Hong Kong, China
A methodological, descriptive study was conducted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.
Time frame: Baseline
For measuring participants' pain related to chemotherpay induced peripheral neuropathy.This scale contains six faces with increasing degree of pain from left to right, where each face is rated on a scale of 10, in which 0 indicates no hurt, 2 indicates little bit hurts, 4 indicates little more hurts, 6 indicates even more hurts, 8 indicated a whole lot of hurts, and 10 indicated the worst hurts. higher scores indicating more severe pain.
Time frame: Baseline
To assess the participants' quality of life. The participants rated how frequently a particular problem occurred in the past month, using a three-point Likert scale (0 = Not at all, 2 = Sometimes, 4 = A lot) for children 5-7 years old and a five-point Likert scale (0 = Never, 1=Almost never, 2=sometimes, 3=often, 4 = Almost always) for children of 8-18 years old and for the parents of patients of all ages. Each item score will be reversely scored and then linearly transformed into 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). The scale score is the average of the total item scores, with higher scores representing better quality of life.
Time frame: Baseline
To ascertain the clinical diagnosis of CIPN in participants. The clinical diagnosis of CIPN could be made if the results of the nerve conduction study are abnormal, with a score of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ≥ 2 after the clinical consultation with a pediatric neurologist on the chemotherapeutic drugs used, cumulative doses, and clinical characteristics and time course of the CIPN symptoms. NCI-CTCAE items including five items: peripheral sensory neuropathy, peripheral motor neuropathy, constipation, diarrhea, and neuralgia. The sum score for the five NCI-CTCAE items was between 0 and 17.
The Hong Kong Polytechnic University
Other
Cross-cultural Adaptation and Validation of the Pediatric Chemotherapy-induced Neuropathy (P-CIN) for Chinese Pediatric Oncology Patients: A Multi-center Study
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