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Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy

NCT07761325 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Aromatherapy

Patients receive aromatherapy via an ultrasonic diffuser combined with standard triple antiemetic therapy.

DRUG

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-18
Primary Completion
2030-08-30
Completion
2030-08-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761325 on ClinicalTrials.gov