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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
374
Patients receive aromatherapy via an ultrasonic diffuser combined with standard triple antiemetic therapy.
Standard prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, and dexamethasone, administered according to international guideline recommendations.
Complete Response (CR) Rate of CINV within 0-120 hours
Time frame: 0-120 hours after chemotherapy (Day 1 to Day 5)
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
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