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Completed

NCT Number: NCT05851625

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

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.

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Key information

Conditions

Pediatric Cancer Chemotherapy Effect Chemotherapy-induced Nausea and Vomiting Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Press needle acupuncture

Device

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

Plesterin

Device

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

Primary outcomes

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

    Time frame: 9 days

    Method instrument for assessing nausea and vomiting consisting of eight statements

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Mashhad University of Medical Sciences

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2023
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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