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

NCT02403037 | Completed DMC

• 1 other identifier: HSEARS20150213001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief 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

Breast Neoplasms; Nausea; Vomiting

Keywords

Breast Neoplasms; Auricular Therapy; Acupressure; Chemotherapy; Nausea; Vomiting

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Feasibility outcome

  Through study completion, an average of 1 year and 4 months

• Consent Rate

  Feasibility outcome

  Through study completion, an average of 1 year and 4 months

• Attrition Rate

  Feasibility outcome

  Through study completion, an average of 1 year and 4 months

• Feasibility of the Study Questionnaires and Auricular Acupressure Protocol

  Feasibility outcome

  Through study completion, an average of 1 year and 4 months

• Potential Adverse Events associated with Auricular Acupressure

  Feasibility outcome

  During the 5-day intervention period

Secondary Outcomes (10)

• Occurrence of Acute Vomiting

  The 2nd day of the first chemotherapy cycle

• Frequency of Acute Vomiting

  The 2nd day of the first chemotherapy cycle

• Occurrence of Acute Nausea

  The 2nd day of the first chemotherapy cycle

• Severity of Acute Nausea

  The 2nd day of the first chemotherapy cycle

• Occurrence of Delayed Vomiting

  The 6th day of the first chemotherapy cycle

Study Arms (3)

True Auricular Acupressure Group

EXPERIMENTAL

Participants in this group will receive standard antiemetics before and during chemotherapy, and a 5-day auricular acupressure treatment protocol for controlling nausea and vomiting during the first cycle of chemotherapy.

Device: True auricular acupressure; Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)

Sham Auricular Acupressure Group

SHAM COMPARATOR

Participants in this group will receive standard antiemetic medications before and during chemotherapy, and a 5-day sham auricular acupressure intervention protocol during the first cycle of chemotherapy.

Device: Sham auricular acupressure; Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)

Standard Care Group

OTHER

Participants in this group will only receive standard anti-emetic treatment before and during chemotherapy.

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

Interventions

True auricular acupressure DEVICE

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

Also known as: Auricular tape with vaccaria seeds

True Auricular Acupressure Group

Sham auricular acupressure DEVICE

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.

Also known as: Auricular tape with Junci Medulla

Sham Auricular Acupressure Group

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

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

Also known as: 5-HT3 receptor antagonists and/or Dexamethasone

Sham Auricular Acupressure Group; Standard Care Group; True Auricular Acupressure Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female patients aged above 18 years old;
• A diagnosis of breast cancer stage I-III;
• Chemotherapy- naive;
• Auricular therapy-naive;
• Be able to communicate in Chinese mandarin;
• Have at least completed a primary school education;
• Agree to participate in the study and be willing to give written informed consent;
• Be scheduled to receive the first cycle of chemotherapy with moderately-high to highly emetogenic potentials;
• Be provided with standard antiemetic medications during chemotherapy.

You may not qualify if:

• Extremely weak, disabled or immunocompromised cancer patients;
• Be unable to follow the study instructions to do AT intervention or other research procedures;
• Have concurrent radiotherapy or other kinds of antineoplastic therapy;
• Currently take part in clinical studies on anti-emetic medications or other kinds of non-pharmacological interventions to control CINV, or other studies which are believed to produce potential interactions with this AT trial;
• Have other health problems which may affect the symptoms of CINV such as gastrointestinal disease, liver disease, migraine, tinnitus and Ménière's disease, etc.;
• Ear skin problems which are not appropriate for auricular acupressure including ear infections, ear scars and rashes, ear frostbite, and ear abscess, etc.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (3)

The Second People's Hospital of Fujian Province

Fuzhou, Fujian, 350003, China

Location

The First People's Hospital of Fujian Province

Fuzhou, Fujian, 350004, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Related Publications (1)

• Tan JY, Molassiotis A, Suen LKP, Liu J, Wang T, Huang HR. Effects of auricular acupressure on chemotherapy-induced nausea and vomiting in breast cancer patients: a preliminary randomized controlled trial. BMC Complement Med Ther. 2022 Mar 24;22(1):87. doi: 10.1186/s12906-022-03543-y.

  PMID: 35331208 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorna SUEN, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

CN (3)