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

Not Applicable

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting; Chemotherapy Effect; Pediatric Cancer
• Interventions: Device: Plesterin; Device: Press needle acupuncture

• Registration Number: NCT05851625
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-06
• Study First Posted: 2023-05-10
• Study Start: 2023-10-16
• Primary Completion: 2024-03-10
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Plesterin	The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.
Acupuncture	Press needle acupuncture	The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.

Primary Outcome Measures

Name	Time	Method
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire	9 days	Method instrument for assessing nausea and vomiting consisting of eight statements

Trial Locations

Locations (1)

RSUPN Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta, DKI Jakarta, Indonesia