Chemotherapy-induced Nausea and Vomiting Clinical Trial
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
Verified date | January 2024 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | December 15, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Dharmais Cancer, Hospital | Jakarta | DKI Jakarta |
Indonesia | Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04054193 -
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
|
Phase 4 | |
Recruiting |
NCT04430361 -
the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
|
Phase 2 | |
Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
Completed |
NCT02285647 -
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
|
Phase 1 | |
Terminated |
NCT01874119 -
Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT01757210 -
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
|
N/A | |
Completed |
NCT01442376 -
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
|
Phase 3 | |
Withdrawn |
NCT00891761 -
A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy
|
Phase 3 | |
Completed |
NCT01031498 -
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
|
Phase 2 | |
Terminated |
NCT02519842 -
Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
|
Phase 3 | |
Recruiting |
NCT03232541 -
The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting
|
N/A | |
Completed |
NCT02909478 -
Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer
|
Phase 3 | |
Terminated |
NCT03237611 -
Low Dose Aprepitant for Patients Receiving Carboplatin
|
Phase 2 | |
Completed |
NCT03649230 -
Observational Study on the Use of Akynzeo® in Patients Receiving HEC
|
||
Not yet recruiting |
NCT02933099 -
Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting
|
Phase 3 | |
Completed |
NCT02557035 -
An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
|
Phase 3 | |
Completed |
NCT00787566 -
Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
|
Phase 2 | |
Completed |
NCT04918069 -
Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN)
|
Phase 2 | |
Completed |
NCT05851625 -
Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
|
N/A | |
Recruiting |
NCT05325190 -
Granisetron Transdermal Patch System for Prevention of CINV by CapeOX
|
Phase 2 |