Clinical trial · Interventional
Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aromatherapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| CINV | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatherapy | Other | — | UNRESOLVED |
| Standard triple antiemetic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm: Aromatherapy + Standard Antiemetic Therapy
- description
- Patients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
- interventionNames
- Other: Aromatherapy
- Drug: Standard triple antiemetic therapy
- type
- ACTIVE_COMPARATOR
- label
- Control Arm: Standard Antiemetic Therapy Alone
- description
- Patients receive standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone) .
- interventionNames
- Drug: Standard triple antiemetic therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available