An interventional study of laserpuncture and Sham Laserpuncture in Chemotherapy-induced Nausea and Vomiting, sponsored by Indonesia University. Completed at 2 sites in Indonesia. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
Chemotherapy is a common treatment for treating cancer. Chemotherapy induced nausea and vomiting (CINV) is nausea and vomiting that occurs after chemotherapy. Complete protection of standard antiemetic drugs against CINV symptoms in children and adolescents receiving moderately and strongly emetogenic chemotherapy drugs was less than 50%.
The side effects of chemotherapy in the form of CINV are so unpleasant that chemotherapy causes extreme anxiety and stress. The psychological characteristics of adolescents who have a greater perception of the changes that occur cause more frequent anxiety which can increase the risk of CINV.
Acupuncture with laserpuncture modality is a non-pharmacological therapy that has a good effect on CINV symptoms in adolescents. This research was conducted for the first time in Brazil in 2019, while in Indonesia there has never been any research on this matter. So it is hoped that this research will be the first research in Indonesia to prove that the effect of laserpuncture plays a role in CINV symptoms in adolescents and can be an additional treatment in standard therapy for CINV problems in adolescents.
This is a clinical trial study to evaluate and compare the effects of laserpuncture and sham laserpuncture as a therapy for Chemotherapy induced nausea and vomiting (CINV) . The subjects are 58 males/female and will be randomly assigned to 2 groups: (1) laserpunctur and (2) Sham laserpuncture. The outcome will be assessed before treatment (baseline), in chemotherapy procedure and 3 days after chemotherapy. Patients and the outcome assessors will be blinded to the group allocation.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 58 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laserpuncture using continous wave, 2 Joule in on condition
Device: laserpuncture
Sham laser using laserpuncture in off condition
Device: Sham Laserpuncture
laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw
Sham laser using laserpuncture in off condition
Rhodes Index nausea, vomiting and Reatching Score (RINVR)
Score for measuring nausea, vomiting and reatching after chemotherapy. minimum score is 0 and maximum score is 32
Time frame: before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy
Screen for Child Anxiety Related Disorders (SCARED)
Score for measuring anxiety for Child. score 25 or more is anxiety. minimum score is 0 and maximum score is 82
Time frame: before Chemotherapy, 3 days after chemotherapy
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Indonesia University