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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Device: laserpuncture; Device: Sham Laserpuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramadia RY Yunita, doctor; Phone Number: 081384859448; Email: ramadiayunita@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 11420
      • Dharmais Cancer, Hospital
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adolescent cancer patients aged 10 - 18 years
2. Patients undergoing chemotherapy with moderate and/or strong emetogenic chemotherapy drugs
3. Patients with CINV and/or at risk of CINV
4. Willing to take part in research until completion
5. The patient has not received acupuncture therapy in the last 1 week

Exclusion Criteria:

1. Patients with cancerous lesions or ulcers at the location of the acupuncture points to be selected
2. Patients with digestive tract organ malignancies with complaints of nausea and vomiting before chemotherapy
3. Patients with unstable hemodynamic conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before Chemotherapy, 3 days after chemotherapy

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI KR RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 23061053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No