Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-13
Brief Title:
Aromatherapy in the Treatment of Early Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Effects of Aromatherapy on Anxiety and Tumor Immunity of Early Breast Cancer Patientsa Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is a major threat to womens 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
Thereforewe 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
Thereforewe 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 61 to 95 in the general populationAmong 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 womens 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
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 womens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None