- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05851625
Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
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.
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) 3 days before chemotherapy; (2) days of chemotherapy; (3) 12 hours after chemotherapy; (4) 3 days after chemotherapy.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wahyuningsih Djaali
- Phone Number: +6281381117386
- Email: inchy86@yahoo.com
Study Locations
-
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 10430
- Recruiting
- RSUPN Dr. Cipto Mangunkusumo
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Contact:
- Wahyuningsih Djaali
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.
|
The plaster used is a round plaster that resembles the shape of an acupuncture press needle.
|
Experimental: Acupuncture
The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.
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Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
Time Frame: 9 days
|
Method instrument for assessing nausea and vomiting consisting of eight statements
|
9 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19944
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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