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Aromatherapy / Aromatherapy / Standard triple antiemetic therapy · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration with no reported results. The study plans to enroll 374 breast cancer patients to test whether aromatherapy added to standard triple antiemetic therapy improves complete response rates in chemotherapy-induced nausea and vomiting (CINV), addressing a clinical gap where 30–50% of guideline-treated patients still experience delayed CINV. Outcomes remain unreported in this registry record.
Phase 3, Interventional, Randomized, Parallel, Open label, Prevention purpose. Breast Cancer, Aromatherapy, Chemotherapy, CINV; age from 18 Years; to 80 Years. Intervention: Experimental Arm: Aromatherapy + Standard Antiemetic Therapy. Compared with: Control Arm: Standard Antiemetic Therapy Alone — Active Comparator. n = 374. Multicenter (specific sites not detailed in registry record)..
This is a Phase 3 trial registration with no reported results. The study plans to enroll 374 breast cancer patients to test whether aromatherapy added to standard triple antiemetic therapy improves complete response rates in chemotherapy-induced nausea and vomiting (CINV), addressing a clinical gap where 30–50% of guideline-treated patients still experience delayed CINV. Outcomes remain unreported in this registry record.
This is a registry record with no results; no outcome data, effect sizes, or safety findings are reported. Results for secondary endpoints (QoL, anxiety, depression, sleep quality, GDF15) and safety are not yet available.
Once results are published, this trial will address whether aromatherapy offers additive benefit to standard triple antiemetic prophylaxis in a population with persistent CINV despite guideline-recommended therapy. The findings may inform supportive care practices if efficacy is demonstrated.
This is a Phase 3 trial registration with no results reported; the study is not yet recruiting and contains only planned design and endpoints.
As stated by the source record.
Quoted from the source exactly as published.
Once results are published, this trial will address whether aromatherapy offers additive benefit to standard triple antiemetic prophylaxis in a population with persistent CINV despite guideline-recommended therapy. The findings may inform supportive care practices if efficacy is demonstrated.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07761325). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 374 participants (ESTIMATED). Conditions: Breast Cancer, Aromatherapy, Chemotherapy, CINV. Interventions: OTHER: Aromatherapy; DRUG: Standard triple antiemetic therapy. Primary outcome measures: Complete Response (CR) Rate of CINV within 0-120 hours , 0-120 hours after chemotherapy (Day 1 to Day 5). 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.
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