Clinical trial · Interventional
TCM as an Adjuvant Treatment in Breast Cancer Patients
A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients
NCT04843865CI-TRIAL-00084235recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Musculoskeletal Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chinese Herbs | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chinese Herbs
- description
- Participants received standardized Chinese Herbs treatment orally twice daily for 1 week.
- interventionNames
- Dietary Supplement: Chinese Herbs
Primary outcomes (1)
- measure
- Feasibility of the study (Adherence)
- timeFrame
- Immediate post 1 week of Chinese Herbs intervention
- description
- The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.
Secondary outcomes (13)
- measure
- Feasibility of the study (Dropout rate)
- timeFrame
- Immediate post 1 week of Chinese Herbs intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (8)
- BACKGROUNDNie 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
- BACKGROUNDSanchez-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
- BACKGROUNDWang 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
- BACKGROUNDYan 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
- BACKGROUNDVahedi 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
- BACKGROUNDLovibond 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
- BACKGROUNDWong 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