Pediatric CancerNCT05851625
Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
A study testing Press needle acupuncture and Plesterin in people with Pediatric Cancer and Chemotherapy-induced Nausea and Vomiting, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Cancer, Chemotherapy-induced Nausea and Vomiting, Chemotherapy Effect
- What is being tested?
- Press needle acupuncture and Plesterin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Oct 2023to 30 Apr 2024
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with cancer who are undergoing chemotherapy.
- Age 6 - 18 years.
- Patients with platelet counts > 20,000/μL and neutrophil values > 1,000/μL.
- Willing to follow the research.
Who cannot join
- Patients with local infection in the puncture area.
- Patients with anatomic abnormalities in the auricle.
- Did not complete the acupuncture therapy until it was finished (three days after chemotherapy).
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.
Read the detailed description
The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.
- Being tested
- Press needle acupuncture, Plesterin
- Keywords
- acupuncture, ear acupuncture, CINV, cancer, press needle
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press needle acupunctureDevice
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.
PlesterinDevice
The plaster used is a round plaster that resembles the shape of an acupuncture press needle.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention. Receives: Device: Plesterin |
| Acupuncture | Experimental | The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention. Receives: Device: Press needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
Method instrument for assessing nausea and vomiting consisting of eight statements
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start16 Oct 2023
- Primary completion10 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Responsible party
- Principal investigator, Wahyuningsih Djaali, Universitas Indonesia
- Investigators
- Wahyuningsih Djaali, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851625
- Sponsor's protocol ID
- 19944
- Status last verified
- May 2024
- First submitted
- 26 Apr 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
- ClinicalTrials.gov ID
- NCT05851625
- Acronym / sponsor ID
- 19944
- Keywords
- acupuncture, ear acupuncture, CINV, cancer, press needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 May 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 cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.
Detailed description
The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlesterinThe control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention. |
| Acupuncture | Experimental | Device: Press needle acupunctureThe intervention group was given press needle acupuncture with standard medical therapy for CINV prevention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients with cancer who are undergoing chemotherapy.
- Age 6 - 18 years.
- Patients with platelet counts > 20,000/μL and neutrophil values > 1,000/μL.
- Willing to follow the research.
Key exclusion criteria (3 listed)
- Patients with local infection in the puncture area.
- Patients with anatomic abnormalities in the auricle.
- Did not complete the acupuncture therapy until it was finished (three days after chemotherapy).
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 |
|---|---|---|
| Press needle acupuncturePress needle acupuncture is a modality of acupuncture using tiny and very thin needles. | Device | Acupuncture |
| PlesterinThe plaster used is a round plaster that resembles the shape of an acupuncture press needle. | Device | Placebo |
Primary outcome
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
Time frame: 9 days
Method instrument for assessing nausea and vomiting consisting of eight statements
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 23 May 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.
Wahyuningsih Djaali principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press needle acupuncture and Plesterin in people with Pediatric Cancer and Chemotherapy-induced Nausea and Vomiting, run by Universitas Indonesia at 1 site 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 4 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 of Nausea, Vomiting, and Retching (RINVR) questionnaire (time frame: 9 days). 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 23 May 2024.