Aromatherapy in the Treatment of Early Breast Cancer

Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety caused by breast cancer itself and adverse reactions of chemotherapy not only affects the patients' quality of life, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even affect anti-tumor immunity. Therefore,we envisage that aromatherapy conbimed with chemotherapy in the treatment of breast cancer in clinical practice has the advantages of improving efficacy and survival. However, there is still a lack of relevant clinical studies. We planned to design a prospective clinical trial to evaluate the efficacy and safety of aromatherapy combined with chemotherapy on anxiety, relevant sympathetic neurotransmitters and tumor immunity in breast cancer patients.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

1. Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.
2. Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant chemotherapy.
3. Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.
4. ECOG physical status score ≤ 2 and expected survival of not less than 3 months.
5. At least one measurable lesion should be present in the imaging examination within 2 weeks prior to enrollment.
6. Adequate reserve of bone marrow function: white blood cell count ≥ 3.0×10\^9/L, neutrophil count ≥ 1.5 × 10\^9/L; Platelet count ≥ 70 × 10\^9/L.
7. Basically normal liver, kidney and cardiac function:total bilirubin≤3 times the upper limit of normal value,Alanine Transaminase/Aspartate Aminotransferase≤2.5 times the upper limit of normal value(patients with liver metastases≤5 times the upper limit of normal value)，serum creatinine≤1.5 times the upper limit of normal value or creatinine clearance rate≥60mL/min, left ventricular ejection fraction (LVEF) ≥ 55%,QTcF(Fridericia correction) ≤ 470 ms.
8. Be able to understand the research process, volunteer to participate in the study, and sign informed consent.

Exclusion Criteria:

1. Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials or suffer from heterosmia.
2. Received surgery within 2 weeks prior to enrollment.
3. Patients with severe cardiovascular and cerebrovascular events within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)
4. Patients with active autoimmune diseases requiring treatment (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years. Patients who need corticosteroid replacement therapy for adrenal insufficiency were excluded.
5. Patients with a definite past medical history or present medical history of neurological or mental disorders, including epilepsy or dementia.
6. The researchers believe that patients are not suitable to participate in any other circumstances of this study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects.

• BACKGROUNDHarbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2. PMID 31548545
• BACKGROUNDXiong SY, Wen HZ, Dai LM, Lou YX, Wang ZQ, Yi YL, Yan XJ, Wu YR, Sun W, Chen PH, Yang SZ, Qi XW, Zhang Y, Wu GY. A brain-tumor neural circuit controls breast cancer progression in mice. J Clin Invest. 2023 Dec 15;133(24):e167725. doi: 10.1172/JCI167725. PMID 37847562
• BACKGROUNDWang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20. PMID 32820237
• BACKGROUNDCarreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan. PMID 33411711
• BACKGROUNDSharma M, Grewal K, Jandrotia R, Batish DR, Singh HP, Kohli RK. Essential oils as anticancer agents: Potential role in malignancies, drug delivery mechanisms, and immune system enhancement. Biomed Pharmacother. 2022 Feb;146:112514. doi: 10.1016/j.biopha.2021.112514. Epub 2021 Dec 25. PMID 34963087
• BACKGROUNDBayala B, Bassole IH, Gnoula C, Nebie R, Yonli A, Morel L, Figueredo G, Nikiema JB, Lobaccaro JM, Simpore J. Chemical composition, antioxidant, anti-inflammatory and anti-proliferative activities of essential oils of plants from Burkina Faso. PLoS One. 2014 Mar 24;9(3):e92122. doi: 10.1371/journal.pone.0092122. eCollection 2014. PMID 24662935
• Peterfalvi A, Miko E, Nagy T, Reger B, Simon D, Miseta A, Czeh B, Szereday L. Much More Than a Pleasant Scent: A Review on Essential Oils Supporting the Immune System. Molecules. 2019 Dec 11;24(24):4530. doi: 10.3390/molecules24244530.