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NCT Number: NCT07761325

Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of 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.

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Key information

Conditions

Breast Cancer Aromatherapy Breast Diseases Breast Neoplasms CINV Chemotherapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatherapy

Other

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

Standard triple antiemetic therapy

Drug

Standard prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, and dexamethasone, administered according to international guideline recommendations.

Primary outcomes

  1. Complete Response (CR) Rate of CINV within 0-120 hours

    Time frame: 0-120 hours after chemotherapy (Day 1 to Day 5)

Secondary outcomes

  1. CR Rate in Acute Phase (0-24 hours)

    Time frame: (0-24 hours)

  2. CR Rate in Delayed Phase (25-120 hours)

    Time frame: 25-120 hours

  3. Complete Control (CC) Rate

    Time frame: 0-120 hours

  4. Total Control (TC) Rate

    Time frame: 0-120 hours

  5. Time to Treatment Failure (TTF)

    Time frame: 0-120 hours

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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