Clinical trial NCT04843865: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Musculoskeletal Pain
Keywords: Chinese herbs
Breast cancer
Aromatase inhibitor-associated musculoskeletal symptoms
Protein profiling
System biology
Syndrome element differentiation
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A quasi-experimental design
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of the study (Adherence)
timeFrame: Immediate post 1 week of Chinese Herbs intervention
Secondary outcomes:
measure: Feasibility of the study (Dropout rate)
timeFrame: Immediate post 1 week of Chinese Herbs intervention
measure: Change in the pain score
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in Syndrome element differentiation
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in stress
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in protein expression
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in Liver Function Test
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in CEA (Carcino-Embryonic Antigen)
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in CRP (C-Reactive Protein)
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in Progesterone
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in Estradiol
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
measure: Change in Cytokine levels of serum
timeFrame: Baseline and immediate post 1 week of Chinese Herbs intervention
Other outcomes:
Locations:
city: Bukit Bintang
country: Malaysia
facility: Tung Shin Hospital
state: Kuala Lumpur
Study officials:
affiliation: Universiti Tunku Abdul Rahman (UTAR)
name: Yang Mooi Lim
role: PRINCIPAL_INVESTIGATOR
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