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

University of Indonesia (UI)

Status: Completed

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

Treatments: Device: Press needle acupuncture; Device: Plesterin

Study type: Interventional

Funder types: Other

Identifiers

NCT05851625

19944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Plesterin

Acupuncture

Experimental group

Description:

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

Treatment:

Device: Press needle acupuncture