Aromatherapy in the Treatment of Early Breast Cancer

Early Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435104
• Other study ID #: SYSKY-2024-063-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jianli J Zhao, doctorate
• Phone: 15920589334
• Email: zhaojli5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

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.
• aromatherapy
Patients will inhale essential oils during the neoadjuvant chemotherapy courses.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (13)

Bayala B, Bassole IH, Gnoula C, Nebie R, Yonli A, Morel L, Figueredo G, Nikiema JB, Lobaccaro JM, Simpore J. Chemical composition, antioxidant, anti-inflammatory and anti-proliferative activities of essential oils of plants from Burkina Faso. PLoS One. 2014 Mar 24;9(3):e92122. doi: 10.1371/journal.pone.0092122. eCollection 2014. — View Citation

Ben-Shaanan TL, Schiller M, Azulay-Debby H, Korin B, Boshnak N, Koren T, Krot M, Shakya J, Rahat MA, Hakim F, Rolls A. Modulation of anti-tumor immunity by the brain's reward system. Nat Commun. 2018 Jul 13;9(1):2723. doi: 10.1038/s41467-018-05283-5. — View Citation

Bhimani RV, Yates R, Bass CE, Park J. Distinct limbic dopamine regulation across olfactory-tubercle subregions through integration of in vivo fast-scan cyclic voltammetry and optogenetics. J Neurochem. 2022 Apr;161(1):53-68. doi: 10.1111/jnc.15577. Epub 2022 Feb 5. — View Citation

Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan. — View Citation

Deng C, Xie Y, Liu Y, Li Y, Xiao Y. Aromatherapy Plus Music Therapy Improve Pain Intensity and Anxiety Scores in Patients With Breast Cancer During Perioperative Periods: A Randomized Controlled Trial. Clin Breast Cancer. 2022 Feb;22(2):115-120. doi: 10.1016/j.clbc.2021.05.006. Epub 2021 May 20. — View Citation

Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2. — View Citation

Kite SM, Maher EJ, Anderson K, Young T, Young J, Wood J, Howells N, Bradburn J. Development of an aromatherapy service at a Cancer Centre. Palliat Med. 1998 May;12(3):171-80. doi: 10.1191/026921698671135743. — View Citation

Peterfalvi A, Miko E, Nagy T, Reger B, Simon D, Miseta A, Czeh B, Szereday L. Much More Than a Pleasant Scent: A Review on Essential Oils Supporting the Immune System. Molecules. 2019 Dec 11;24(24):4530. doi: 10.3390/molecules24244530. — View Citation

Sharma M, Grewal K, Jandrotia R, Batish DR, Singh HP, Kohli RK. Essential oils as anticancer agents: Potential role in malignancies, drug delivery mechanisms, and immune system enhancement. Biomed Pharmacother. 2022 Feb;146:112514. doi: 10.1016/j.biopha.2021.112514. Epub 2021 Dec 25. — View Citation

Wang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20. — View Citation

Xiong SY, Wen HZ, Dai LM, Lou YX, Wang ZQ, Yi YL, Yan XJ, Wu YR, Sun W, Chen PH, Yang SZ, Qi XW, Zhang Y, Wu GY. A brain-tumor neural circuit controls breast cancer progression in mice. J Clin Invest. 2023 Dec 15;133(24):e167725. doi: 10.1172/JCI167725. — View Citation

Zhang Z, Liu Q, Wen P, Zhang J, Rao X, Zhou Z, Zhang H, He X, Li J, Zhou Z, Xu X, Zhang X, Luo R, Lv G, Li H, Cao P, Wang L, Xu F. Activation of the dopaminergic pathway from VTA to the medial olfactory tubercle generates odor-preference and reward. Elife. 2017 Dec 18;6:e25423. doi: 10.7554/eLife.25423. — View Citation

Zhao ZJ, Sun YL, Ruan XF. Bornyl acetate: A promising agent in phytomedicine for inflammation and immune modulation. Phytomedicine. 2023 Jun;114:154781. doi: 10.1016/j.phymed.2023.154781. Epub 2023 Mar 22. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety score	Changes of anxiety scores (Hamilton Anxiety Scale and State-trait anxiety inventory scale) before and after two neoadjuvant chemotherapy courses.	before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
Secondary	Overall Survival, OS	The time from the start of randomization to death due to any cause	2 years
Secondary	Quality of life scale score,QoL	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.	before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
Secondary	Pathologic complete response,pCR	Proportion of patients with pathologic complete response after neoadjuvant chemotherapy	2 years
Secondary	Disease-free survival,DFS	The time from diagnosis to first recurrence or death of the patient	2 years
Secondary	Complete response,CR	All target lesions disappeared, no new lesions appeared, and tumor markers remained normal for at least 4 weeks.	2 years
Secondary	Partial response,PR	The sum of the maximum diameters of the target lesions is reduced by=30%,maintained for at least 4 weeks.	2 years
Secondary	Stable disease,SD	The sum of the maximum diameters of the target lesions is within the prescribed range of partial response and progressive disease.	2 years
Secondary	Progressive disease,PD	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.	2 years
Secondary	Objective Response Rate, ORR	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).	2 years
Secondary	Clinical Benefit Rate, CBR	Proportion of confirmed complete response, partial response, or stable disease = 24 weeks.	24 weeks after enrollment
Secondary	Anxiety rating scale	The scores of self-rating anxiety scale (SAS) before treatment, after each treatment and 3 months after the last treatment.	before treatment and 3 months after the last treatment
Secondary	Sleep rating scale	The scores of Pittsburgh sleep quality index(PSQI) before treatment, after each treatment and 3 months after the last treatment.	before treatment and 3 months after the last treatment
Secondary	Depression scale	The scores of Hamilton Depression Scale(HAMD) before treatment and after 2 times of treatment.	before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)