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

NCT06121414 | Completed

• 1 other identifier: 23061053
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Screen for Child Anxiety Related Disorders (SCARED)

  before Chemotherapy, 3 days after chemotherapy

Study Arms (2)

Laserpuncture

EXPERIMENTAL

Laserpuncture using continous wave, 2 Joule in on condition

Device: laserpuncture

Sham Laserpuncture

SHAM COMPARATOR

Sham laser using laserpuncture in off condition

Device: Sham Laserpuncture

Interventions

laserpuncture DEVICE

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

Laserpuncture

Sham Laserpuncture DEVICE

Sham laser using laserpuncture in off condition

Sham Laserpuncture

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Dharmais Cancer, Hospital

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• KEPK FKUI KR RSCM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 8, 2023
• Study Start: October 2, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)