- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403037
Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients
The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fujian
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Fuzhou, Fujian, China, 350014
- Fujian Provincial Cancer Hospital
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Fuzhou, Fujian, China, 350003
- The Second People's Hospital of Fujian Province
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Fuzhou, Fujian, China, 350004
- The First People's Hospital of Fujian Province
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: True Auricular Acupressure Group
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.
|
A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds.
Other Names:
5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Other Names:
|
Sham Comparator: Sham Auricular Acupressure Group
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.
|
5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Other Names:
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.
Other Names:
|
Other: Standard Care Group
Participants in this group will only receive standard anti-emetic treatment before and during chemotherapy.
|
5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Rate
Time Frame: Through study completion, an average of 1 year and 4 months
|
Feasibility outcome
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Through study completion, an average of 1 year and 4 months
|
Consent Rate
Time Frame: Through study completion, an average of 1 year and 4 months
|
Feasibility outcome
|
Through study completion, an average of 1 year and 4 months
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Attrition Rate
Time Frame: Through study completion, an average of 1 year and 4 months
|
Feasibility outcome
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Through study completion, an average of 1 year and 4 months
|
Feasibility of the Study Questionnaires and Auricular Acupressure Protocol
Time Frame: Through study completion, an average of 1 year and 4 months
|
Feasibility outcome
|
Through study completion, an average of 1 year and 4 months
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Potential Adverse Events associated with Auricular Acupressure
Time Frame: During the 5-day intervention period
|
Feasibility outcome
|
During the 5-day intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Acute Vomiting
Time Frame: The 2nd day of the first chemotherapy cycle
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Secondary outcome
|
The 2nd day of the first chemotherapy cycle
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Frequency of Acute Vomiting
Time Frame: The 2nd day of the first chemotherapy cycle
|
Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Occurrence of Acute Nausea
Time Frame: The 2nd day of the first chemotherapy cycle
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Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Severity of Acute Nausea
Time Frame: The 2nd day of the first chemotherapy cycle
|
Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Occurrence of Delayed Vomiting
Time Frame: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Frequency of Delayed Vomiting
Time Frame: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Occurrence of Delayed Nausea
Time Frame: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Severity of Delayed Nausea
Time Frame: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Anticipatory Nausea and Vomiting
Time Frame: The 1st day of the second chemotherapy cycle
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The measure is a composite
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The 1st day of the second chemotherapy cycle
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Quality of Life Status
Time Frame: The 21st day of the first chemotherapy cycle
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Secondary outcome
|
The 21st day of the first chemotherapy cycle
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lorna SUEN, PhD, The Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Signs and Symptoms, Digestive
- Breast Diseases
- Breast Neoplasms
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Antiemetics
- Emetics
Other Study ID Numbers
- HSEARS20150213001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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