TCM as an Adjuvant Treatment in Breast Cancer Patients

Official title

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

Overview

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.

Detailed 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.

Interventions

• Dietary supplement Chinese Herbs
  Chinese Herbs

Primary outcome measures

• Feasibility of the study (Adherence) [Time frame: Immediate post 1 week of Chinese Herbs intervention]

Secondary outcome measures (12)

• Feasibility of the study (Dropout rate) [Time frame: Immediate post 1 week of Chinese Herbs intervention]
• Change in the pain score [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in Syndrome element differentiation [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life) [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in stress [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ) [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in protein expression [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in Liver Function Test [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in CEA (Carcino-Embryonic Antigen) [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in CRP (C-Reactive Protein) [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in Progesterone [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]
• Change in Estradiol [Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Malaysia · 1 center

• Tung Shin Hospital — Bukit Bintang

Publications

• 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. doi: 10.3892/br.2015.537. Epub 2015 Nov 5. PMID 26870326
• Sanchez-Vidana 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. PMID 28250795
• 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. doi: 10.1016/0304-3959(96)03147-8. PMID 8951936
• 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. PMID 28702077
• 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. PMID 22952508
• 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. doi: 10.1016/0005-7967(94)00075-u. PMID 7726811
• 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. PMID 23710222
• 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. doi: 10.1214/10-AOAS341. PMID 21593992

Identifiers

NCT: NCT04843865 · UTAR- 8068/000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗