A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843865
• Other study ID #: UTAR- 8068/000
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: April 2024

Study information

• Verified date: November 2022
• Source: Universiti Tunku Abdul Rahman
• Contact: Chin Long Poo
• Phone: 0178853596
• Email: athrunjoe[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment.

Description:

The previous studies have reported that adjuvant Chinese herbs therapy can improve the survival of breast cancer patients by alleviating the side effects of conventional treatments. Protein expression determines the phenotype of a patient that contributes to the onset of side effects in breast cancer patients caused by conventional treatment. Chinese herbs treatment will alleviate the treatment-related side effects by altering the protein expression in the patients. Associating changes in protein levels with the onset of side effects caused by conventional treatments could be used to identify clinically relevant diagnostic biomarkers. In addition, a set of proteome that is being expressed at diseased state will exhibit the phenotype that is also correlated to the TCM syndrome differentiation. Hence, this study aims to determine the proteome profile for the syndrome differentiation of breast cancer patients treated with adjuvant Chinese herbs for musculoskeletal pain. A quasi-experimental study with purposive sampling will be conducted on 30 breast cancer patients recruited from Tung Shin hospital. All participants will be invited to complete a structured questionnaire to collect their demographic information, pain score, syndrome element differentiation, quality of life, stress, body constitution and other relevant information, including cancer type, cancer stage, and cancer treatment. The questionnaires will be self-administered either at the outpatient waiting room or in the ward of the study hospital. Blood of the patients will be collected for determination of protein expression, biochemical markers and cytokines. The study is an in-point analysis where 2 time-points of data collection and analysis will be carried out at baseline, and immediate post Chinese herbs treatment. Informed consent will be obtained before participant enrolment according to a clinical trial protocol. Statistical differences for protein expression, biochemical markers, cytokines and mean pain score before and after Chinese herbs treatment will be compared using the paired-sample t test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women as determined by cessation of menses for at least 1 year or FSH>20 mIU/mL

• Histology confirmed stage 2 to 3 hormone-receptor positive breast cancer patient

• Currently taking letrozole for at least 1 month

• Reported ongoing musculoskeletal pain or stiffness, which started or worsened after initiation of letrozole

• Had a baseline average pain score over the past week on the Brief Pain Inventory Short Form (BPI-SF) of =4 points on a scale of 0 to 10.

• Completed all indicated surgery, chemotherapy and radiation therapy

• Agreed to take prescribed Chinese herbs

• No evidence of distant metastasis

• Follow-up for the duration of the study

• No acute disease in the past month

• Able to communicate to practitioner and interviewer

• Willing to give informed consent

Exclusion Criteria:

• Pregnant or nursing woman or woman of childbearing potential without effective method of birth control.

• Patients who default subsequent follow-up/ has irregular follow-up.

• Patients who directly involved in other study at the same time.

• History of non-compliance to medical regime and patients who are unwilling or unable to comply with the protocol.

• Bedridden and/ or cancer metastasis to bone/ lung.

• Concurrent infection requiring intravenous antibiotics

• History of allergy to Chinese herbs

• Had previously received Chinese herbs for their AI-induced musculoskeletal symptoms

• Had received Chinese herbs within one month prior to study entry

• Current use of steroids or narcotics for pain relief within the past 2 weeks

• Subjects with acute onset of a chronic illness or with acute disease in the past month or had pre-existing chronic diseases

• Patients with concomitant severe illness or metastatic disease (poorly controlled hypertension, hypothyroidism, diabetes mellitus, liver diseases, osteoarthritis, rheumatoid arthritis, gout or neuropathic arthropathy, autoimmune or inflammatory joint disease, bone fracture, stroke)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Musculoskeletal Pain

Intervention

Dietary Supplement:
• Chinese Herbs
Chinese Herbs

Locations

Country	Name	City	State
Malaysia	Tung Shin Hospital	Bukit Bintang	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman

Country where clinical trial is conducted

Malaysia, 

References & Publications (8)

Karpievitch YV, Polpitiya AD, Anderson GA, Smith RD, Dabney AR. Liquid Chromatography Mass Spectrometry-Based Proteomics: Biological and Technological Aspects. Ann Appl Stat. 2010;4(4):1797-1823. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. — View Citation

Nie J, Zhao C, Deng LI, Chen J, Yu B, Wu X, Pang P, Chen X. Efficacy of traditional Chinese medicine in treating cancer. Biomed Rep. 2016 Jan;4(1):3-14. Epub 2015 Nov 5. — View Citation

Sánchez-Vidaña DI, Rajwani R, Wong MS. The Use of Omic Technologies Applied to Traditional Chinese Medicine Research. Evid Based Complement Alternat Med. 2017;2017:6359730. doi: 10.1155/2017/6359730. Epub 2017 Jan 31. Review. — View Citation

Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53. — View Citation

Wang XS, Mendoza TR, Gao SZ, Cleeland CS. The Chinese version of the Brief Pain Inventory (BPI-C): its development and use in a study of cancer pain. Pain. 1996 Oct;67(2-3):407-16. — View Citation

Wong W, Lam CL, Wong VT, Yang ZM, Ziea ET, Kwan AK. Validation of the constitution in chinese medicine questionnaire: does the traditional chinese medicine concept of body constitution exist? Evid Based Complement Alternat Med. 2013;2013:481491. doi: 10.1155/2013/481491. Epub 2013 Apr 24. — View Citation

Yan E, Song J, Liu C, Hong W. A research on syndrome element differentiation based on phenomenology and mathematical method. Chin Med. 2017 Jul 10;12:19. doi: 10.1186/s13020-017-0141-1. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the study (Adherence)	The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.	Immediate post 1 week of Chinese Herbs intervention
Secondary	Feasibility of the study (Dropout rate)	The feasibility will be assessed by dropout rate of the patients.	Immediate post 1 week of Chinese Herbs intervention
Secondary	Change in the pain score	The pain score of breast cancer patients will be assessed by Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a validated and reliable tool used to assess the severity or intensity of pain on scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean a worse outcome.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in Syndrome element differentiation	Syndrome Element Differentiation rating scale will be used to determine the syndrome element differentiation of the patients. Syndrome Element Differentiation rating scale can quantify the syndrome elements of this patient based on the clinical manifestations. The quantitative output weight values of syndrome elements are acquired from clinical input data based on the severity and frequency of each sign and symptom. Based on the quantitative output value, the syndrome elements can then be categorized into four levels of health state or severity: normal (<70), mild (= 70 to <100), moderate (=100 to <150), and severe (= 150).	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)	The quality of life will be assessed by the WHO-BREF questionnaire in this study. The WHOQOL-BREF instrument comprises 26 items, measuring the following broad domains: physical health, psychological health, social relationships, and environment, with scores ranging from 0 to 100. The four domain scores denote an individual's perception of the quality of life in each domain. Domain scores are scaled in a positive direction in which higher scores denote a higher quality of life.; the minimum and maximum values: 0, 100; higher scores mean a better outcome.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in stress	The Depression Anxiety Stress Scales (DASS) is a self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. A short version, the DASS 21 scale consists of a list of 21 symptoms with 7 item per scale, each of which is to be rated on a four-point scale of how much you had that symptom in the last week from 'never' to 'most of the time'. In this study, stress will be determined by stress domain of DASS-21 which consists of 7 items.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)	The body constitution will be determined by Constitution in Chinese Medicine Questionnaire (CCMQ). It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.; the minimum and maximum values: 0, 100; higher scores mean a worse outcome.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in protein expression	The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in Liver Function Test	The liver function of the patients will be determined by measuring the alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in CEA (Carcino-Embryonic Antigen)	Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in CRP (C-Reactive Protein)	Change in CRP (C-Reactive Protein) will be determined by laboratory examination.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in Progesterone	Change in Progesterone will be determined by laboratory examination.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in Estradiol	Change in Estradiol will be determined by laboratory examination.	Baseline and immediate post 1 week of Chinese Herbs intervention
Secondary	Change in Cytokine levels of serum	The cytokines in serum samples of breast cancer patients will be detected by the Quantibody array, multiplexed sandwich enzyme-linked immunosorbent assay (ELISA) based quantitative array platform (Genomax technology) for quantitative measurement of cytokines in human serum. The unit of measurement for the cytokines is the same.	Baseline and immediate post 1 week of Chinese Herbs intervention