Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients

Conditions
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Pediatric Cancer, Chemotherapy-induced Nausea and Vomiting, Chemotherapy Effect

Intervention / Treatment
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* Device: Press needle acupuncture
* Device: Plesterin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention. | Device: Plesterin<br>* The plaster used is a round plaster that resembles the shape of an acupuncture press needle.<br>|
| Experimental: Acupuncture<br>The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention. | Device: Press needle acupuncture<br>* Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire | Method instrument for assessing nausea and vomiting consisting of eight statements | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, ear acupuncture, CINV, cancer, press needle