Early Breast Cancer
Conditions
Keywords
Early breast Cancer, Anxiety, Aromatherapy, Neoadjuvant chemotherapy
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.
Interventions
OTHERneoadjuvant 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.
OTHERaromatherapy
Patients will inhale essential oils during the neoadjuvant chemotherapy courses.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The research model consists of two arms# 1. armA:neoadjuvant chemotherapy 2. armB:neoadjuvant chemotherapy+aromatherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Pathologic complete response,pCR | 2 years | Proportion of patients with pathologic complete response after neoadjuvant chemotherapy |
| Disease-free survival,DFS | 2 years | The time from diagnosis to first recurrence or death of the patient |
| Complete response,CR | 2 years | All target lesions disappeared, no new lesions appeared, and tumor markers remained normal for at least 4 weeks. |
| 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. |
| 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. |
| Overall Survival, OS | 2 years | The time from the start of randomization to death due to any cause |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactJianli J Zhao, doctorate
Backup ContactErwei E Song, doctorate
Outcome results
None listed