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

NCT05851625 | Completed DMC

• 1 other identifier: 19944
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

acupuncture; ear acupuncture; CINV; cancer; press needle

Outcome Measures

Primary Outcomes (1)

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

  Method instrument for assessing nausea and vomiting consisting of eight statements

  9 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.

Device: Plesterin

Acupuncture

EXPERIMENTAL

The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.

Device: Press needle acupuncture

Interventions

Press needle acupuncture DEVICE

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Acupuncture

Plesterin DEVICE

The plaster used is a round plaster that resembles the shape of an acupuncture press needle.

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indonesia University: lead
• Mashhad University of Medical Sciences: collaborator

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wahyuningsih Djaali

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Indonesia University

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 10, 2023
• Study Start: October 16, 2023
• Primary Completion: March 10, 2024
• Study Completion: April 30, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)