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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Press needle acupuncture

Plesterin

About this trial

This is an interventional prevention trial for Pediatric Cancer focused on measuring acupuncture, ear acupuncture, CINV, cancer, press needle

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

RSUPN Dr. Cipto MangunkusumoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Method instrument for assessing nausea and vomiting consisting of eight statements

Secondary Outcome Measures

Full Information

NCT ID

NCT05851625

First Posted

April 26, 2023

Last Updated

October 17, 2023

Sponsor

Indonesia University

Collaborators

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05851625

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 16, 2023 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

Collaborators

Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

acupuncture, ear acupuncture, CINV, cancer, press needle

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Press needle acupuncture

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Plesterin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Method instrument for assessing nausea and vomiting consisting of eight statements

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wahyuningsih Djaali

Phone

+6281381117386

inchy86@yahoo.com

Facility Information:

Facility Name

RSUPN Dr. Cipto Mangunkusumo

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wahyuningsih Djaali

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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