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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121414
• Other study ID #: 23061053
• Status: Completed
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Device:
• laserpuncture
laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw
• Sham Laserpuncture
Sham laser using laserpuncture in off condition

Locations

Country	Name	City	State
Indonesia	Dharmais Cancer, Hospital	Jakarta	DKI Jakarta
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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