Aromatherapy, Breast Cancer, Chemotherapy, CINV
Conditions
Brief 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). 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.
Interventions
OTHERAromatherapy
Patients receive aromatherapy via an ultrasonic diffuser combined with standard triple antiemetic therapy.
DRUGStandard triple antiemetic therapy
Standard prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, and dexamethasone, administered according to international guideline recommendations.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR) Rate of CINV within 0-120 hours | 0-120 hours after chemotherapy (Day 1 to Day 5) |
Secondary
| Measure | Time frame |
|---|---|
| CR Rate in Acute Phase (0-24 hours) | (0-24 hours) |
| CR Rate in Delayed Phase (25-120 hours) | 25-120 hours |
| Complete Control (CC) Rate | 0-120 hours |
| Total Control (TC) Rate | 0-120 hours |
| Time to Treatment Failure (TTF) | 0-120 hours |
Outcome results
None listed