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

Sponsor

Indonesia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05851625

Collaborator

Mashhad University of Medical Sciences (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer Chemotherapy-induced Nausea and Vomiting Chemotherapy Effect	Device: Press needle acupuncture Device: Plesterin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.	Device: Plesterin The plaster used is a round plaster that resembles the shape of an acupuncture press needle.
Experimental: Acupuncture The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.	Device: Press needle acupuncture Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Device: Plesterin

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

Experimental: Acupuncture

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

Device: Press needle acupuncture

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

Outcome Measures

Primary Outcome Measures

Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire [9 days]
Method instrument for assessing nausea and vomiting consisting of eight statements

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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).