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

U

University of Indonesia (UI)

Status

Completed

Conditions

Chemotherapy-induced Nausea and Vomiting

Treatments

Device: laserpuncture
Device: Sham Laserpuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06121414
23061053

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

Laserpuncture
Experimental group
Description:
Laserpuncture using continous wave, 2 Joule in on condition
Treatment:
Device: laserpuncture
Sham Laserpuncture
Sham Comparator group
Description:
Sham laser using laserpuncture in off condition
Treatment:
Device: Sham Laserpuncture

Trial contacts and locations

2

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Central trial contact

Ramadia RY Yunita, doctor

Data sourced from clinicaltrials.gov

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