Chemotherapy-induced Nausea and VomitingNCT06121414
Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy
A study testing laserpuncture in people with Chemotherapy-induced Nausea and Vomiting, run by Universitas Indonesia at 2 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- laserpuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesIndonesia
- Study dates
- 2 Oct 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Dharmais Cancer, Hospital
Jakarta, DKI Jakarta, 11420
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- laserpuncture, Sham Laserpuncture
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laserpunctureDevice
laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw
Sham LaserpunctureDevice
Sham laser using laserpuncture in off condition
| Study group | Role | What they receive |
|---|---|---|
| Laserpuncture | Experimental | Laserpuncture using continous wave, 2 Joule in on condition Receives: Device: laserpuncture |
| Sham Laserpuncture | Sham comparator | Sham laser using laserpuncture in off condition Receives: Device: Sham Laserpuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start2 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramadia Yunita, Universitas Indonesia
- Investigators
- KEPK FKUI KR RSCM, Principal investigator, The Ethics Committee of the Faculty Of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121414
- Sponsor's protocol ID
- 23061053
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06121414
- Acronym / sponsor ID
- 23061053
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laserpuncture | Experimental | Device: laserpunctureLaserpuncture using continous wave, 2 Joule in on condition |
| Sham Laserpuncture | Sham comparator | Device: Sham LaserpunctureSham laser using laserpuncture in off condition |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laserpuncturelaserpuncture use continous wave,dose 2 Joule, 785nm, 50mw | Device | Laserpuncture |
| Sham LaserpunctureSham laser using laserpuncture in off condition | Device | Sham Laserpuncture |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEPK FKUI KR RSCM principal investigator
The Ethics Committee of the Faculty Of Medicine, University of Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laserpuncture in people with Chemotherapy-induced Nausea and Vomiting, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhodes Index nausea, vomiting and Reatching Score (RINVR) (time frame: before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.