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

NCT07761325 | Not Yet Recruiting Phase 3

• 1 other identifier: SYSKY-2026-462-01
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Aromatherapy; Chemotherapy; CINV

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental Arm: Aromatherapy + Standard Antiemetic Therapy

EXPERIMENTAL

Patients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).

Other: Aromatherapy; Drug: Standard triple antiemetic therapy

Control Arm: Standard Antiemetic Therapy Alone

ACTIVE COMPARATOR

Patients receive standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone) .

Drug: Standard triple antiemetic therapy

Interventions

Aromatherapy OTHER

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

Experimental Arm: Aromatherapy + Standard 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.

Control Arm: Standard Antiemetic Therapy Alone; Experimental Arm: Aromatherapy + Standard Antiemetic Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 18, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: August 12, 2026

Record last verified: 2026-06