Effectiveness of Laserpuncture and Standard Antiemetic on... | NCT06121414

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

NCT06121414

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jan 29, 2024Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

laserpuncture
Sham Laserpuncture

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2023Actual

Primary Completion Date

Dec 15, 2023Actual

Completion Date

Dec 15, 2023Actual

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Nov 5, 2023

First Posted Date

Nov 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2024

Last Update Posted Date

Jan 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
laserpuncture	Device	laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw	Laserpuncture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
KEPK FKUI KR RSCM	The Ethics Committee of the Faculty Of Medicine, University of Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dharmais Cancer, Hospital		Jakarta	DKI Jakarta	11420	Indonesia
Cipto Mangunkusumo Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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