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

NCT ID: NCT05851625

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Plesterin

Intervention Type: DEVICE

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

Acupuncture

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

Group Type: EXPERIMENTAL

Press needle acupuncture

Intervention Type: DEVICE

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

Interventions

Press needle acupuncture

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

Intervention Type: DEVICE

Plesterin

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Wahyuningsih Djaali

Lecturer of Indonesia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wahyuningsih Djaali

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

RSUPN Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

19944

Identifier Type: -

Identifier Source: org_study_id