Clinical trial NCT02403037: Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients
Official title: The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Nausea
Vomiting
Keywords: Breast Neoplasms
Auricular Therapy
Acupressure
Chemotherapy
Nausea
Vomiting
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 protocol for managing nausea and vomiting in female breast cancer patients undergoing chemotherapy. The objectives of this study will be: (1) to pilot the methodological procedure of the randomized controlled trial using a standard auricular acupressure protocol for controlling CINV; (2) to determine the recruitment rate and attrition rate during the whole study period; (3) to determine the feasibility of the study questionnaires and auricular acupressure protocol to the study participants; (4) to identify potential adverse events associated with auricular acupressure; (5) to preliminarily examine the effects of auricular acupressure on CINV and QoL in female breast cancer patients receiving chemotherapy; (6) to explore patients' experience in completing the trial and receiving the intervention; and (7) to refine the study protocol for a future multicenter, large-scale randomized controlled trial.

A three-parallel-arm, placebo-controlled randomized pilot 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, 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 without any acupoint stimulation, 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, the attrition rate during the whole study period, feasibility of the study questionnaires and auricular acupressure protocol to the study participants, and AT-related adverse events. The future main study outcomes will also be measured including acuteCINV, delayed CINV, anticipatory CINV, and quality of life. After completing the pilot clinical trial, a nested qualitative interview will be conducted to explore participants' experience in completing the trial and receiving the intervention.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, an average of 1 year and 4 months
measure: Consent Rate
timeFrame: Through study completion, an average of 1 year and 4 months
measure: Attrition Rate
timeFrame: Through study completion, an average of 1 year and 4 months
measure: Feasibility of the Study Questionnaires and Auricular Acupressure Protocol
timeFrame: Through study completion, an average of 1 year and 4 months
measure: Potential Adverse Events associated with Auricular Acupressure
timeFrame: During the 5-day intervention period
Secondary outcomes:
measure: Occurrence of Acute Vomiting
timeFrame: The 2nd day of the first chemotherapy cycle
measure: Frequency of Acute Vomiting
timeFrame: The 2nd day of the first chemotherapy cycle
measure: Occurrence of Acute Nausea
timeFrame: The 2nd day of the first chemotherapy cycle
measure: Severity of Acute Nausea
timeFrame: The 2nd day of the first chemotherapy cycle
measure: Occurrence of Delayed Vomiting
timeFrame: The 6th day of the first chemotherapy cycle
measure: Frequency of Delayed Vomiting
timeFrame: The 6th day of the first chemotherapy cycle
measure: Occurrence of Delayed Nausea
timeFrame: The 6th day of the first chemotherapy cycle
measure: Severity of Delayed Nausea
timeFrame: The 6th day of the first chemotherapy cycle
measure: Anticipatory Nausea and Vomiting
timeFrame: The 1st day of the second chemotherapy cycle
measure: Quality of Life Status
timeFrame: The 21st day of the first chemotherapy cycle
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Second People's Hospital of Fujian Province
state: Fujian
city: Fuzhou
country: China
facility: The First People's Hospital of Fujian Province
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Lorna SUEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.