Clinical trial NCT06121414: Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rhodes Index nausea, vomiting and Reatching Score (RINVR)
timeFrame: before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy
Secondary outcomes:
Other outcomes:
measure: Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: before Chemotherapy, 3 days after chemotherapy
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Dharmais Cancer, Hospital
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty Of Medicine, University of Indonesia
name: KEPK FKUI KR RSCM
role: PRINCIPAL_INVESTIGATOR
References: