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

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851625
• Other study ID #: 19944
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Indonesia University
• Contact: Wahyuningsih Djaali
• Phone: +6281381117386
• Email: inchy86[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 30, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chemotherapy Effect
• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Pediatric Cancer
• Vomiting

Intervention

Device:
• Press needle acupuncture
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.
• Plesterin
The plaster used is a round plaster that resembles the shape of an acupuncture press needle.

Locations

Country	Name	City	State
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Mashhad University of Medical Sciences

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire	Method instrument for assessing nausea and vomiting consisting of eight statements	9 days