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

Information source: The Hong Kong Polytechnic University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms; Nausea; Vomiting

Intervention: True auricular acupressure (Auricular tape with vaccaria seeds) (Device); Sham auricular acupressure (Auricular tape with Junci Medulla) (Device); Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: The Hong Kong Polytechnic University

Official(s) and/or principal investigator(s):
Lorna SUEN, PhD, Principal Investigator, Affiliation: The Hong Kong Polytechnic University

Overall contact:
Jing-Yu TAN, Phone: (86) 13107636830, Email: jing-yu.tan@connect.polyu.hk

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 the occurrence, frequency and severity of acute/delayed nausea and vomiting among groups during the intervention period; (2) There will be no significant difference in the occurrence, frequency and severity of 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.

Clinical Details

Official title: The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot and Feasibility Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Recruitment Rate

Consent Rate

Attrition Rate

Secondary outcome:

Occurrence of Acute Vomiting

Frequency of Acute Vomiting

Occurrence of Acute Nausea

Severity of Acute Nausea

Occurrence of Delayed Vomiting

Frequency of Delayed Vomiting

Occurrence of Delayed Nausea

Severity of Delayed Nausea

Occurrence, Frequency and Severity of Anticipatory Nausea and Vomiting

Quality of Life Status

Potential Adverse Events associated with Auricular Acupressure

Detailed description: Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side-effects among cancer patients undergoing chemotherapy. Despite steady progresses in antiemetic prophylaxis and treatment during the past decades, approximately half of cancer patients receiving moderately to highly emetogenic chemotherapy still experience significant nausea and vomiting. Considering the facts that CINV is difficult to be completely controlled by antiemetics along, healthcare professionals has explored the role of non-pharmacological interventions as adjunctive therapy for controlling CINV. Among which, auricular therapy (AT) is a promising approach but the evidence has still not been concluded. The aim of this study is to test the feasibility of a randomized controlled trial using auricular acupressure for managing nausea and vomiting in female breast cancer patients undergoing chemotherapy. The objectives of this study will be: (1) to pilot the methodological procedures of the randomized controlled trial using a standard auricular acupressure protocol for controlling CINV; (2) to determine the recruitment rate and the attrition rate during the whole study periods; (3) to examine the effects of auricular acupressure on the occurrence, frequency and severity of CINV as well as the QoL status in female breast cancer patients receiving chemotherapy; (4) to identify potential adverse events associated with auricular acupressure; (5) to explore patients' experiences and burdens on completing the trial and the reasons for study attrition; and (6) to refine the study protocol for a future multicenter, large-scale randomized controlled trial. A three-parallel-arm, placebo-controlled randomized pilot and feasibility study will be adopted. One hundred and fourteen breast cancer patients scheduled to receive the first cycle of chemotherapy will be recruited from three provincial hospitals in Fuzhou, China, and will be randomly assigned to one of the three groups: the true AT group, the sham AT group or the standard care group. Participants in the true AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the specific ear acupoints, and participants in the sham AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the same acupoints as in the true AT group but no pressure will be applied, while participants in the standard care group will only be provided with the standard anti-emetic medications. The feasibility outcomes will be the recruitment rate and consent rate during the recruitment stage, and the attrition rate during the study periods. The future main study outcomes will also be measured including the occurrence, frequency and severity of nausea and vomiting, quality of life (QoL) status and potential adverse events associated with AT. After completing the pilot clinical trial, a nested qualitative study, the focus group interview will be conducted to explore participants' experiences and burdens on completing the trial and the reasons for study attrition.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Adult female patients aged less than 50 years old;

- A diagnosis of breast cancer stage I-III;

- Chemotherapy- naive;

- Auricular therapy-naive;

- Be able to communicate in Chinese mandarin;

- Had at least completed a primary school education;

- Agree to participate in the study and be willing to give written informed consent;

- Scheduled to receive the first cycle of anthracycline-based chemotherapy with

moderately high emetogenic potentials;

- Be provided with standard antiemetic medications during chemotherapy.

Exclusion Criteria:

- Extremely weak, disabled or immunocompromised patients;

- Not cooperate with the study intervention and any other procedures;

- Have concurrent radiotherapy or other kinds of antineoplastic therapy;

- Currently participate in studies on anti-emetic drugs or other kinds of

non-pharmacological interventions to control CINV, or other studies which may have some interactions with the study;

- Have other health problems which may affect the symptoms of nausea and vomiting

during chemotherapy including a series of gastrointestinal diseases, liver disease, migraine, tinnitus and Ménière's disease, etc.;

- Have a history of chronic alcohol use which could contribute to minimal level of

nausea or vomiting;

- Ear skin problems which are not appropriate for auricular acupressure including

infections, scars, rashes, frostbite, moles, ear abrasions or abscess, etc.

Locations and Contacts

Jing-Yu TAN, Phone: (86) 13107636830, Email: jing-yu.tan@connect.polyu.hk

Fujian Provincial Cancer Hospital, Fuzhou, Fujian 350014, China; Recruiting
Jing-Yu TAN, Phone: (86) 13107636830, Email: jing-yu.tan@connect.polyu.hk

The First People's Hospital of Fujian Province, Fuzhou, Fujian 350004, China; Recruiting
Jing-Yu TAN, Phone: (86) 13107636830, Email: jing-yu.tan@connect.polyu.hk

The Second People's Hospital of Fujian Province, Fuzhou, Fujian 350003, China; Not yet recruiting
Jing-Yu TAN, Phone: (86) 13107636830, Email: jing-yu.tan@connect.polyu.hk

Additional Information

Starting date: July 2015
Last updated: July 14, 2015

Page last updated: August 23, 2015

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