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

Not Applicable

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Device: laserpuncture; Device: Sham Laserpuncture

• Registration Number: NCT06121414
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2023-10-02
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-08
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laserpuncture	laserpuncture	Laserpuncture using continous wave, 2 Joule in on condition
Sham Laserpuncture	Sham Laserpuncture	Sham laser using laserpuncture in off condition

Primary Outcome Measures

Name	Time	Method
Rhodes Index nausea, vomiting and Reatching Score (RINVR)	before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy	Score for measuring nausea, vomiting and reatching after chemotherapy. minimum score is 0 and maximum score is 32

Trial Locations

Locations (2)

Dharmais Cancer, Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia