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

NCT ID: NCT06121414

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2023-12-15

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laserpuncture

Laserpuncture using continous wave, 2 Joule in on condition

Group Type: EXPERIMENTAL

laserpuncture

Intervention Type: DEVICE

laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw

Sham Laserpuncture

Sham laser using laserpuncture in off condition

Group Type: SHAM_COMPARATOR

Sham Laserpuncture

Intervention Type: DEVICE

Sham laser using laserpuncture in off condition

Interventions

laserpuncture

laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw

Intervention Type: DEVICE

Sham Laserpuncture

Sham laser using laserpuncture in off condition

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Ramadia Yunita

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KEPK FKUI KR RSCM

Role: PRINCIPAL_INVESTIGATOR

The Ethics Committee of the Faculty Of Medicine, University of Indonesia

Locations

Dharmais Cancer, Hospital

Jakarta, DKI Jakarta, Indonesia

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

23061053

Identifier Type: -

Identifier Source: org_study_id