Aromatherapy in the Treatment of Early Breast Cancer

Phase

Condition

N/A

Treatment

aromatherapy

neoadjuvant chemotherapy

Clinical Study ID

NCT06435104

SYSKY-2024-063-02

Ages 18-80
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult female patients (age 18-80 years) with early breast cancer confirmed bypathology.
Patients have not received any anti-tumor treatment,and are planning to receiveneoadjuvant chemotherapy.
Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.
ECOG physical status score ≤ 2 and expected survival of not less than 3 months.
At least one measurable lesion should be present in the imaging examination within 2weeks prior to enrollment.
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.
Basically normal liver, kidney and cardiac function:total bilirubin≤3 times theupper limit of normal value,Alanine Transaminase/Aspartate Aminotransferase≤2.5times the upper limit of normal value(patients with liver metastases≤5 times theupper limit of normal value)，serum creatinine≤1.5 times the upper limit of normalvalue or creatinine clearance rate≥60mL/min, left ventricular ejection fraction (LVEF) ≥ 55%,QTcF(Fridericia correction) ≤ 470 ms.
Be able to understand the research process, volunteer to participate in the study,and sign informed consent.

Exclusion

Exclusion Criteria:

Patients who are not able to receive aromatherapy:be allergic to aromatherapymaterials or suffer from heterosmia.
Received surgery within 2 weeks prior to enrollment.
Patients with severe cardiovascular and cerebrovascular events within 12 months,including but not limited to unstable angina, myocardial infarction, cerebralhemorrhage, and cerebral infarction (except asymptomatic lacunar infarctionrequiring no treatment)
Patients with active autoimmune diseases requiring treatment (e.g., corticosteroidsor immunosuppressive drugs) within the past 2 years. Patients who needcorticosteroid replacement therapy for adrenal insufficiency were excluded.
Patients with a definite past medical history or present medical history ofneurological or mental disorders, including epilepsy or dementia.
The researchers believe that patients are not suitable to participate in any othercircumstances of this study, which may interfere with the accompanying diseases orconditions of the study, or have any serious medical obstacles that may affect thesafety of the subjects.

Study Design

aromatherapy

July 01, 2024

January 31, 2027

Study Description

Breast cancer is the most common malignant tumor in women all over the world. In China, the incidence of breast cancer is increasing, especially in the economically developed cities. Studies have shown that the breast cancer patients have a higher incidence of anxiety and depression to the general population. Tumor burden is an important chronic stressor that can cause a wide range of negative emotions, such as anxiety and depression. According to the data published by the World Health Organization, the incidence of depression in cancer patients is between 20% to 45%, which is far more than the incidence of 6.1% to 9.5% in the general population.Among them, the depression tendency of breast cancer patients is particularly obvious, and up to 80% of breast cancer patients suffer from different degrees of depression. Depression and anxiety have a crucial influence on the physiological and psychological function, treatment compliance and the quality of life of breast cancer patients, and may even be an important factor affecting the mortality of breast cancer patients.

Therefore, how to improve the anxiety of breast cancer patients to improve the quality of life and even the survival time of patients has vital clinical value. Considering the adverse reactions and tolerance of current anti-anxiety drugs, more mild and effective anti-anxiety methods are expected in clinical practice. Among them, as an important means of rehabilitation treatment, aromatherapy has obtained surprising data in the prevention of adverse reactions of chemotherapy and the improvement of insomnia, so the value of aromatherapy in the improvement of anxiety is also expected.

In conclusion, 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 and depression caused by breast cancer disease itself and adverse reactions of chemotherapy not only affects the quality of life of patients, 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 have influence on tumor immunity. However, there is still lack of relevant clinical researches. Therefore, we plan to design a prospective clinical study to evaluate the effect of aromatherapy combined with neoadjuvant chemotherapy on anxiety, sympathetic neurotransmitters and tumor immunity in early breast cancer patients.

Connect with a study center

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510120
China
Site Not Available

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