Aromatherapy in the Treatment of Early Breast Cancer
- Conditions
- Early Breast Cancer
- Interventions
- Other: neoadjuvant chemotherapyOther: aromatherapy
- Registration Number
- NCT06435104
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.
- Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant 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 2 weeks 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 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.
- Be able to understand the research process, volunteer to participate in the study, and sign informed consent.
- Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials 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, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)
- 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.
- Patients with a definite past medical history or present medical history of neurological or mental disorders, including epilepsy or dementia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description neoadjuvant chemotherapy neoadjuvant chemotherapy Patients will receive effective neoadjuvant chemotherapy for at least 2 courses. neoadjuvant chemotherapy+aromatherapy neoadjuvant chemotherapy Patients will receive effective neoadjuvant chemotherapy for at least 2 courses, and the aromatherapy is recommended to continue throughout neoadjuvant chemotherapy. neoadjuvant chemotherapy+aromatherapy aromatherapy Patients will receive effective neoadjuvant chemotherapy for at least 2 courses, and the aromatherapy is recommended to continue throughout neoadjuvant chemotherapy.
- Primary Outcome Measures
Name Time Method Change in anxiety score before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days) Changes of anxiety scores (Hamilton Anxiety Scale and State-trait anxiety inventory scale) before and after two neoadjuvant chemotherapy courses.
- Secondary Outcome Measures
Name Time Method Overall Survival, OS 2 years The time from the start of randomization to death due to any cause
Quality of life scale score,QoL before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days) The function or quality of a patient's physical, psychological, and social adaptability is also known as quality, which is assessed according to the EROTC C30 scale.
Disease-free survival,DFS 2 years The time from diagnosis to first recurrence or death of the patient
Stable disease,SD 2 years The sum of the maximum diameters of the target lesions is within the prescribed range of partial response and progressive disease.
Objective Response Rate, ORR 2 years The proportion of patients with a tumor volume reduction of ≥30% and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR).
Clinical Benefit Rate, CBR 24 weeks after enrollment Proportion of confirmed complete response, partial response, or stable disease ≥ 24 weeks.
Pathologic complete response,pCR 2 years Proportion of patients with pathologic complete response after neoadjuvant chemotherapy
Partial response,PR 2 years The sum of the maximum diameters of the target lesions is reduced by≥30%,maintained for at least 4 weeks.
Complete response,CR 2 years All target lesions disappeared, no new lesions appeared, and tumor markers remained normal for at least 4 weeks.
Progressive disease,PD 2 years The sum of the maximum diameters of the target lesions increases by at least 20%, and their absolute value of diameters increases by at least 5mm, or new lesions appear.
Anxiety rating scale before treatment and 3 months after the last treatment The scores of self-rating anxiety scale (SAS) before treatment, after each treatment and 3 months after the last treatment.
Sleep rating scale before treatment and 3 months after the last treatment The scores of Pittsburgh sleep quality index(PSQI) before treatment, after each treatment and 3 months after the last treatment.
Depression scale before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days) The scores of Hamilton Depression Scale(HAMD) before treatment and after 2 times of treatment.
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China