Breast NeoplasmsNCT02403037
Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients
A study testing True auricular acupressure and Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) in people with Breast Neoplasms and Nausea, run by The Hong Kong Polytechnic University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Nausea, Vomiting
- What is being tested?
- True auricular acupressure and Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second People's Hospital of Fujian Province
Fuzhou, Fujian, 350003
The First People's Hospital of Fujian Province
Fuzhou, Fujian, 350004
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms, Nausea, Vomiting
- Being tested
- True auricular acupressure, Sham auricular acupressure, Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)
- Keywords
- Breast Neoplasms, Auricular Therapy, Acupressure, Chemotherapy, Nausea, Vomiting
- Medical subject headings
- Breast Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True auricular acupressureDevice
Also called Auricular tape with vaccaria seeds
A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds.
Sham auricular acupressureDevice
Also called Auricular tape with Junci Medulla
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.
Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)Drug
Also called 5-HT3 receptor antagonists and/or Dexamethasone
5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| True Auricular Acupressure Group | Experimental | 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. Receives: Device: True auricular acupressure; Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) |
| Sham Auricular Acupressure Group | Sham comparator | 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. Receives: Device: Sham auricular acupressure; Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) |
| Standard Care Group | Other | Participants in this group will only receive standard anti-emetic treatment before and during chemotherapy. Receives: Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Feasibility outcome
Measured: Through study completion, an average of 1 year and 4 months
Consent Rate
Feasibility outcome
Measured: Through study completion, an average of 1 year and 4 months
Attrition Rate
Feasibility outcome
Measured: Through study completion, an average of 1 year and 4 months
Feasibility of the Study Questionnaires and Auricular Acupressure Protocol
Feasibility outcome
Measured: Through study completion, an average of 1 year and 4 months
Potential Adverse Events associated with Auricular Acupressure
Feasibility outcome
Measured: During the 5-day intervention period
Secondary outcomes (10)
Occurrence of Acute Vomiting
Secondary outcome
Measured: The 2nd day of the first chemotherapy cycle
Frequency of Acute Vomiting
Secondary outcome
Measured: The 2nd day of the first chemotherapy cycle
Occurrence of Acute Nausea
Secondary outcome
Measured: The 2nd day of the first chemotherapy cycle
Severity of Acute Nausea
Secondary outcome
Measured: The 2nd day of the first chemotherapy cycle
Occurrence of Delayed Vomiting
Secondary outcome
Measured: The 6th day of the first chemotherapy cycle
Frequency of Delayed Vomiting
Secondary outcome
Measured: The 6th day of the first chemotherapy cycle
Occurrence of Delayed Nausea
Secondary outcome
Measured: The 6th day of the first chemotherapy cycle
Severity of Delayed Nausea
Secondary outcome
Measured: The 6th day of the first chemotherapy cycle
Anticipatory Nausea and Vomiting
The measure is a composite
Measured: The 1st day of the second chemotherapy cycle
Quality of Life Status
Secondary outcome
Measured: The 21st day of the first chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorna Suen, The Hong Kong Polytechnic University
- Investigators
- Lorna SUEN, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403037
- Sponsor's protocol ID
- HSEARS20150213001
- Status last verified
- May 2017
- First submitted
- 19 Mar 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35331208
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02403037
- Acronym / sponsor ID
- HSEARS20150213001
- Conditions
- Breast Neoplasms, Nausea, Vomiting
- Keywords
- Breast Neoplasms, Auricular Therapy, Acupressure, Chemotherapy, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True Auricular Acupressure Group | Experimental | Device: True auricular acupressure, Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)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. |
| Sham Auricular Acupressure Group | Sham comparator | Device: Sham auricular acupressure, Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)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. |
| Standard Care Group | Other | Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)Participants in this group will only receive standard anti-emetic treatment before and during chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True auricular acupressureAlso: Auricular tape with vaccaria seedsA 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds. | Device | True Auricular Acupressure Group |
| Sham auricular acupressureAlso: Auricular tape with Junci MedullaA 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. | Device | Sham Auricular Acupressure Group |
| Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)Also: 5-HT3 receptor antagonists and/or Dexamethasone5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting. | Drug | Sham Auricular Acupressure Group, Standard Care Group, True Auricular Acupressure Group |
Primary outcome
Recruitment Rate
Time frame: Through study completion, an average of 1 year and 4 months
Feasibility outcome
Consent Rate
Time frame: Through study completion, an average of 1 year and 4 months
Feasibility outcome
Attrition Rate
Time frame: Through study completion, an average of 1 year and 4 months
Feasibility outcome
Feasibility of the Study Questionnaires and Auricular Acupressure Protocol
Time frame: Through study completion, an average of 1 year and 4 months
Feasibility outcome
Potential Adverse Events associated with Auricular Acupressure
Time frame: During the 5-day intervention period
Feasibility outcome
10 secondary outcomes
Occurrence of Acute Vomiting
Time frame: The 2nd day of the first chemotherapy cycle
Frequency of Acute Vomiting
Time frame: The 2nd day of the first chemotherapy cycle
Occurrence of Acute Nausea
Time frame: The 2nd day of the first chemotherapy cycle
Severity of Acute Nausea
Time frame: The 2nd day of the first chemotherapy cycle
Occurrence of Delayed Vomiting
Time frame: The 6th day of the first chemotherapy cycle
Frequency of Delayed Vomiting
Time frame: The 6th day of the first chemotherapy cycle
Occurrence of Delayed Nausea
Time frame: The 6th day of the first chemotherapy cycle
Severity of Delayed Nausea
Time frame: The 6th day of the first chemotherapy cycle
Anticipatory Nausea and Vomiting
Time frame: The 1st day of the second chemotherapy cycle
Quality of Life Status
Time frame: The 21st day of the first chemotherapy cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 35331208Tan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna SUEN, PhD principal investigator
The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True auricular acupressure and Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) in people with Breast Neoplasms and Nausea, run by The Hong Kong Polytechnic University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study completion, an average of 1 year and 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.