TCM as an Adjuvant Treatment in Breast Cancer Patients

NCT04843865 | Recruiting DMC

• 1 other identifier: UTAR- 8068/000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Musculoskeletal Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Feasibility of the study (Dropout rate)

  Immediate post 1 week of Chinese Herbs intervention

• Change in the pain score

  Baseline and immediate post 1 week of Chinese Herbs intervention

• Change in Syndrome element differentiation

  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)

  Baseline and immediate post 1 week of Chinese Herbs intervention

• Change in stress

  Baseline and immediate post 1 week of Chinese Herbs intervention

Study Arms (1)

Chinese Herbs

EXPERIMENTAL

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

Dietary Supplement: Chinese Herbs

Interventions

Chinese Herbs DIETARY_SUPPLEMENT

Chinese Herbs

Chinese Herbs

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Tung Shin Hospital

Bukit Bintang, Kuala Lumpur, 55100, Malaysia

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Mooi Lim

  Universiti Tunku Abdul Rahman (UTAR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin Long Poo

CONTACT

0178853596; athrunjoe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A quasi-experimental design

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 14, 2021
• Study Start: April 22, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)