Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients

NCT02403037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2017-05-31

No results posted yet for this study

Summary

To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial using a standard auricular acupressure protocol for managing nausea and vomiting in a homogenous group of female breast cancer patients undergoing chemotherapy.

The null hypotheses of this study are: (1) There will be no significant difference in acute/delayed nausea and vomiting among groups during the intervention period; (2) There will be no significant difference in anticipatory nausea and vomiting among groups before the second cycle of chemotherapy; (3) There will be no significant difference in quality of life status among groups at the end of the first cycle of chemotherapy.

Conditions

Interventions

DEVICE

True auricular acupressure

A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds.

DEVICE

Sham auricular acupressure

A 5-day sham auricular acupressure at the same acupoints as in the true auricular acupressure arm using Junci Medulla but no pressure will be applied.

DRUG

Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)

5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Lorna SUEN, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02403037 on ClinicalTrials.gov