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NCT Number: NCT06121414

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

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dharmais Cancer, Hospital, Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laserpuncture

Device

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

Sham Laserpuncture

Device

Sham laser using laserpuncture in off condition

Primary outcomes

  1. Rhodes Index nausea, vomiting and Reatching Score (RINVR)

    Time frame: 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

Other outcomes

  1. Screen for Child Anxiety Related Disorders (SCARED)

    Time frame: before Chemotherapy, 3 days after chemotherapy

    Score for measuring anxiety for Child. score 25 or more is anxiety. minimum score is 0 and maximum score is 82

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2023
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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