TCM as an Adjuvant Treatment in Breast Cancer Patients

Tunku Abdul Rahman University (UTAR)

Status

Enrolling

Conditions

Musculoskeletal Pain

Breast Cancer

Treatments

Dietary Supplement: Chinese Herbs

Study type

Interventional

Funder types

Other

Identifiers

NCT04843865

UTAR- 8068/000

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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)