Breast CancerPhase 3NCT07761325
Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
A Phase 3 study testing Aromatherapy and Standard triple antiemetic therapy in people with Breast Cancer and Aromatherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Aromatherapy, Chemotherapy
- What is being tested?
- Aromatherapy and Standard triple antiemetic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2026to 30 Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed breast cancer (aged 18-80 years, inclusive).
- Scheduled to receive or currently receiving intravenous chemotherapy, with at least 2 planned cycles.
- Planned use of guideline-recommended triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
- ECOG performance status ≤ 2 and life expectancy ≥ 3 months.
- Chemotherapy regimen classified as highly emetogenic risk according to CSCO, NCCN, or MASCC/ESMO antiemetic guidelines.
- Able to understand the study procedures, voluntarily participate, and provide written informed consent.
Who cannot join
- History of allergy to essential oils.
- History of vestibular dysfunction or intestinal obstruction.
- Major cardiovascular or cerebrovascular event within the past 12 months (e.g., unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction; asymptomatic lacunar infarction not requiring treatment is allowed).
- Pregnancy, lactation, or possibility of pregnancy without willingness to use contraception.
- History or current diagnosis of significant neurological or psychiatric disorders, including epilepsy or dementia.
- Poor compliance anticipated, or any other condition that the investigator considers inappropriate for participation.
About this study
Official title: A Phase III Randomized Controlled Trial of Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Despite guideline-recommended triple prophylaxis (5-HT3 antagonist, NK-1 antagonist, dexamethasone), 30-50% of patients still develop delayed CINV. Aromatherapy with lemon, lavender, and peppermint essential oils may provide additive benefit through olfactory-limbic and vagal pathways, but phase III evidence is lacking. 374 patients (aged 18-80) scheduled for at least two HEC cycles will be randomized 1:1, stratified by prior CINV. On chemo day, aromatherapy starts 30 min before and continues until 2 h after chemotherapy; on days 2-5, inhalation is at least 2 h daily.Primary endpoint: complete response (no vomiting, no rescue antiemetic) over 0-120 h. Key secondary endpoints: acute and delayed CR rates, complete/total control rates, time to treatment failure, quality of life (FLIE), anxiety, depression, sleep quality, and safety. Exploratory: plasma GDF15 dynamics and predictive value.
- Conditions
- Breast Cancer, Aromatherapy, Chemotherapy, CINV
- Being tested
- Aromatherapy, Standard triple antiemetic therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Patients receive aromatherapy via an ultrasonic diffuser combined with standard triple antiemetic therapy.
Standard triple antiemetic therapyDrug
Standard prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, and dexamethasone, administered according to international guideline recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Aromatherapy + Standard Antiemetic Therapy | Experimental | Patients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone). Receives: Other: Aromatherapy; Drug: Standard triple antiemetic therapy |
| Control Arm: Standard Antiemetic Therapy Alone | Active comparator | Patients receive standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone) . Receives: Drug: Standard triple antiemetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate of CINV within 0-120 hours
Measured: 0-120 hours after chemotherapy (Day 1 to Day 5)
Secondary outcomes (5)
CR Rate in Acute Phase (0-24 hours)
Measured: (0-24 hours)
CR Rate in Delayed Phase (25-120 hours)
Measured: 25-120 hours
Complete Control (CC) Rate
Measured: 0-120 hours
Total Control (TC) Rate
Measured: 0-120 hours
Time to Treatment Failure (TTF)
Measured: 0-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start18 Aug 2026 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761325
- Sponsor's protocol ID
- SYSKY-2026-462-01
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Trial of Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT07761325
- Acronym / sponsor ID
- SYSKY-2026-462-01
- Conditions
- Breast Cancer, Aromatherapy, Chemotherapy, CINV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 18 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 12 Aug 2026 (actual)
- 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.
This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Despite guideline-recommended triple prophylaxis (5-HT3 antagonist, NK-1 antagonist, dexamethasone), 30-50% of patients still develop delayed CINV. Aromatherapy with lemon, lavender, and peppermint essential oils may provide additive benefit through olfactory-limbic and vagal pathways, but phase III evidence is lacking. 374 patients (aged 18-80) scheduled for at least two HEC cycles will be randomized 1:1, stratified by prior CINV. On chemo day, aromatherapy starts 30 min before and continues until 2 h after chemotherapy; on days 2-5, inhalation is at least 2 h daily.Primary endpoint: complete response (no vomiting, no rescue antiemetic) over 0-120 h. Key secondary endpoints: acute and delayed CR rates, complete/total control rates, time to treatment failure, quality of life (FLIE), anxiety, depression, sleep quality, and safety. Exploratory: plasma GDF15 dynamics and predictive value.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Aromatherapy + Standard Antiemetic Therapy | Experimental | Other: Aromatherapy, Drug: Standard triple antiemetic therapyPatients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone). |
| Control Arm: Standard Antiemetic Therapy Alone | Active comparator | Drug: Standard triple antiemetic therapyPatients receive standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone) . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed breast cancer (aged 18-80 years, inclusive).
- Scheduled to receive or currently receiving intravenous chemotherapy, with at least 2 planned cycles.
- Planned use of guideline-recommended triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
- ECOG performance status ≤ 2 and life expectancy ≥ 3 months.
- Chemotherapy regimen classified as highly emetogenic risk according to CSCO, NCCN, or MASCC/ESMO antiemetic guidelines.
Key exclusion criteria (6 listed)
- History of allergy to essential oils.
- History of vestibular dysfunction or intestinal obstruction.
- Major cardiovascular or cerebrovascular event within the past 12 months (e.g., unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction; asymptomatic lacunar infarction not requiring treatment is allowed).
- Pregnancy, lactation, or possibility of pregnancy without willingness to use contraception.
- History or current diagnosis of significant neurological or psychiatric disorders, including epilepsy or dementia.
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 |
|---|---|---|
| AromatherapyPatients receive aromatherapy via an ultrasonic diffuser combined with standard triple antiemetic therapy. | Other | Experimental Arm: Aromatherapy + Standard Antiemetic Therapy |
| Standard triple antiemetic therapyStandard prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, and dexamethasone, administered according to international guideline recommendations. | Drug | Control Arm: Standard Antiemetic Therapy Alone, Experimental Arm: Aromatherapy + Standard Antiemetic Therapy |
Primary outcome
Complete Response (CR) Rate of CINV within 0-120 hours
Time frame: 0-120 hours after chemotherapy (Day 1 to Day 5)
5 secondary outcomes
CR Rate in Acute Phase (0-24 hours)
Time frame: (0-24 hours)
CR Rate in Delayed Phase (25-120 hours)
Time frame: 25-120 hours
Complete Control (CC) Rate
Time frame: 0-120 hours
Total Control (TC) Rate
Time frame: 0-120 hours
Time to Treatment Failure (TTF)
Time frame: 0-120 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aromatherapy and Standard triple antiemetic therapy in people with Breast Cancer and Aromatherapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 6 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Complete Response (CR) Rate of CINV within 0-120 hours (time frame: 0-120 hours after chemotherapy (Day 1 to Day 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.