Chemotherapy-induced Nausea and Vomiting
Conditions
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.
Interventions
DEVICElaserpuncture
laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw
DEVICESham Laserpuncture
Sham laser using laserpuncture in off condition
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rhodes Index nausea, vomiting and Reatching Score (RINVR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Screen for Child Anxiety Related Disorders (SCARED) | 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 |
Countries
Indonesia
Outcome results
None listed