Effectiveness of Laserpuncture and Antiemetic on RINVR Scores in Adolescent Undergoing Chemotherapy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effectiveness of Combined Laserpuncture With Antiemetic Therapy on the Rhodes Index of Nausea, Vomiting and Reatching (RINVR) Scores in Adolescent Cancer Patients Undergoing Chemotherapy

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Device: laserpuncture
* Device: Sham Laserpuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent cancer patients aged 10 - 18 years Patients undergoing chemotherapy with moderate and/or strong emetogenic chemotherapy drugs Patients with CINV and/or at risk of CINV Willing to take part in research until completion The patient has not received acupuncture therapy in the last 1 week Exclusion Criteria: Patients with cancerous lesions or ulcers at the location of the acupuncture points to be selected Patients with digestive tract organ malignancies with complaints of nausea and vomiting before chemotherapy Patients with unstable hemodynamic conditions

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laserpuncture<br>Laserpuncture using continous wave, 2 Joule in on condition | Device: laserpuncture<br>* laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw<br>|
| Sham Comparator: Sham Laserpuncture<br>Sham laser using laserpuncture in off condition | Device: Sham Laserpuncture<br>* Sham laser using laserpuncture in off condition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy |