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Clinical Trials/NCT05851625
NCT05851625
Completed
Not Applicable

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

Indonesia University1 site in 1 country64 target enrollmentOctober 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
Indonesia University
Enrollment
64
Locations
1
Primary Endpoint
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
Status
Completed
Last Updated
last year

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
October 16, 2023
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wahyuningsih Djaali

Lecturer of Indonesia University

Indonesia University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire

Time Frame: 9 days

Method instrument for assessing nausea and vomiting consisting of eight statements

Study Sites (1)

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