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NCT06435104

PHASE2

Aromatherapy in the Treatment of Early Breast Cancer

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

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Aromatherapy on Anxiety and Tumor Immunity of Early Breast Cancer Patients,a Pilot Study

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-07

Completion Date

2027-01

Last Updated

2024-07-09

Healthy Volunteers

Conditions

Early Breast Cancer

Interventions

OTHER

neoadjuvant chemotherapy

The neoadjuvant chemotherapy plan will be selected according to the recommendations of the NCCN guidelines and the Chinese CSCO guidelines for early breast cancer.The neoadjuvant chemotherapy plans include:AC-T(HP),TCb(HP),AC-TCb, in which A represents anthracycline, C represents cyclophosphamide, T represents taxane, Cb represents carboplatin, H represents trastuzumab, and P represents pertuzumab.

OTHER

aromatherapy

Patients will inhale essential oils during the neoadjuvant chemotherapy courses.

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.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China