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 RateConsent Rate Attrition Rate
Secondary outcome: Occurrence of Acute VomitingFrequency 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
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