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

Primary Purpose

Breast Cancer, Musculoskeletal Pain

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Chinese Herbs
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Chinese herbs, Breast cancer, Aromatase inhibitor-associated musculoskeletal symptoms, Protein profiling, System biology, Syndrome element differentiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Tung Shin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chinese Herbs

Arm Description

Participants received standardized Chinese Herbs treatment orally twice daily for 1 week.

Outcomes

Primary Outcome Measures

Feasibility of the study (Adherence)
The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.

Secondary Outcome Measures

Feasibility of the study (Dropout rate)
The feasibility will be assessed by dropout rate of the patients.
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.
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).
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.
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.
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.
Change in protein expression
The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
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.
Change in CEA (Carcino-Embryonic Antigen)
Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.
Change in CRP (C-Reactive Protein)
Change in CRP (C-Reactive Protein) will be determined by laboratory examination.
Change in Progesterone
Change in Progesterone will be determined by laboratory examination.
Change in Estradiol
Change in Estradiol will be determined by laboratory examination.
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.

Full Information

First Posted
March 19, 2021
Last Updated
November 2, 2022
Sponsor
Universiti Tunku Abdul Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT04843865
Brief Title
A Systemic Approach to Study the Traditional Chinese Medicine 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Musculoskeletal Pain
Keywords
Chinese herbs, Breast cancer, Aromatase inhibitor-associated musculoskeletal symptoms, Protein profiling, System biology, Syndrome element differentiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A quasi-experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Herbs
Arm Type
Experimental
Arm Description
Participants received standardized Chinese Herbs treatment orally twice daily for 1 week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chinese Herbs
Intervention Description
Chinese Herbs
Primary Outcome Measure Information:
Title
Feasibility of the study (Adherence)
Description
The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.
Time Frame
Immediate post 1 week of Chinese Herbs intervention
Secondary Outcome Measure Information:
Title
Feasibility of the study (Dropout rate)
Description
The feasibility will be assessed by dropout rate of the patients.
Time Frame
Immediate post 1 week of Chinese Herbs intervention
Title
Change in the pain score
Description
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.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in Syndrome element differentiation
Description
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).
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)
Description
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.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in stress
Description
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.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)
Description
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.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in protein expression
Description
The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in Liver Function Test
Description
The liver function of the patients will be determined by measuring the alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in CEA (Carcino-Embryonic Antigen)
Description
Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in CRP (C-Reactive Protein)
Description
Change in CRP (C-Reactive Protein) will be determined by laboratory examination.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in Progesterone
Description
Change in Progesterone will be determined by laboratory examination.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in Estradiol
Description
Change in Estradiol will be determined by laboratory examination.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention
Title
Change in Cytokine levels of serum
Description
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.
Time Frame
Baseline and immediate post 1 week of Chinese Herbs intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin Long Poo
Phone
0178853596
Email
athrunjoe@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Mooi Lim
Organizational Affiliation
Universiti Tunku Abdul Rahman (UTAR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tung Shin Hospital
City
Bukit Bintang
State/Province
Kuala Lumpur
ZIP/Postal Code
55100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
King Keong Chung
Phone
0122027322
Email
chungkk@tungshin.com.my
First Name & Middle Initial & Last Name & Degree
Yang Mooi Lim

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26870326
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. doi: 10.3892/br.2015.537. Epub 2015 Nov 5.
Results Reference
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PubMed Identifier
28250795
Citation
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.
Results Reference
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PubMed Identifier
8951936
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. doi: 10.1016/0304-3959(96)03147-8.
Results Reference
background
PubMed Identifier
28702077
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.
Results Reference
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PubMed Identifier
22952508
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.
Results Reference
background
PubMed Identifier
7726811
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. doi: 10.1016/0005-7967(94)00075-u.
Results Reference
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PubMed Identifier
23710222
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.
Results Reference
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PubMed Identifier
21593992
Citation
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.
Results Reference
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A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients

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