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TCM as an Adjuvant Treatment in Breast Cancer Patients

NCT ID: NCT04843865

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Musculoskeletal Pain

Keywords

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Chinese herbs Breast cancer Aromatase inhibitor-associated musculoskeletal symptoms Protein profiling System biology Syndrome element differentiation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A quasi-experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chinese Herbs

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

Group Type EXPERIMENTAL

Chinese Herbs

Intervention Type DIETARY_SUPPLEMENT

Chinese Herbs

Interventions

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Chinese Herbs

Chinese Herbs

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiti Tunku Abdul Rahman

OTHER

Sponsor Role lead

Responsible Party

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Yang Mooi Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Mooi Lim

Role: PRINCIPAL_INVESTIGATOR

Universiti Tunku Abdul Rahman (UTAR)

Locations

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Tung Shin Hospital

Bukit Bintang, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Chin Long Poo

Role: CONTACT

Phone: 0178853596

Email: [email protected]

Facility Contacts

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King Keong Chung

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26870326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28250795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8951936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28702077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22952508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7726811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23710222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21593992 (View on PubMed)

Other Identifiers

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UTAR- 8068/000

Identifier Type: -

Identifier Source: org_study_id