Breast Neoplasms Clinical Trial
Official title:
The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
Verified date | May 2017 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | October 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Fujian Provincial Cancer Hospital | Fuzhou | Fujian |
China | The First People's Hospital of Fujian Province | Fuzhou | Fujian |
China | The Second People's Hospital of Fujian Province | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | Feasibility outcome | Through study completion, an average of 1 year and 4 months | |
Primary | Consent Rate | Feasibility outcome | Through study completion, an average of 1 year and 4 months | |
Primary | Attrition Rate | Feasibility outcome | Through study completion, an average of 1 year and 4 months | |
Primary | Feasibility of the Study Questionnaires and Auricular Acupressure Protocol | Feasibility outcome | Through study completion, an average of 1 year and 4 months | |
Primary | Potential Adverse Events associated with Auricular Acupressure | Feasibility outcome | During the 5-day intervention period | |
Secondary | Occurrence of Acute Vomiting | Secondary outcome | The 2nd day of the first chemotherapy cycle | |
Secondary | Frequency of Acute Vomiting | Secondary outcome | The 2nd day of the first chemotherapy cycle | |
Secondary | Occurrence of Acute Nausea | Secondary outcome | The 2nd day of the first chemotherapy cycle | |
Secondary | Severity of Acute Nausea | Secondary outcome | The 2nd day of the first chemotherapy cycle | |
Secondary | Occurrence of Delayed Vomiting | Secondary outcome | The 6th day of the first chemotherapy cycle | |
Secondary | Frequency of Delayed Vomiting | Secondary outcome | The 6th day of the first chemotherapy cycle | |
Secondary | Occurrence of Delayed Nausea | Secondary outcome | The 6th day of the first chemotherapy cycle | |
Secondary | Severity of Delayed Nausea | Secondary outcome | The 6th day of the first chemotherapy cycle | |
Secondary | Anticipatory Nausea and Vomiting | The measure is a composite | The 1st day of the second chemotherapy cycle | |
Secondary | Quality of Life Status | Secondary outcome | The 21st day of the first chemotherapy cycle |
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