TCM as an Adjuvant Treatment in Breast Cancer Patients

Last updated: December 30, 2024
Sponsor: Universiti Tunku Abdul Rahman
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Muscle Pain

Acute Pain

Treatment

Chinese Herbs

Clinical Study ID

NCT04843865
UTAR- 8068/000
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal women as determined by cessation of menses for at least 1 year orFSH>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 afterinitiation of letrozole

  • Had a baseline average pain score over the past week on the Brief Pain InventoryShort 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

Exclusion Criteria:

  • Pregnant or nursing woman or woman of childbearing potential without effectivemethod 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 unableto 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 pastmonth or had pre-existing chronic diseases

  • Patients with concomitant severe illness or metastatic disease (poorly controlledhypertension, hypothyroidism, diabetes mellitus, liver diseases, osteoarthritis,rheumatoid arthritis, gout or neuropathic arthropathy, autoimmune or inflammatoryjoint disease, bone fracture, stroke)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Chinese Herbs
Phase:
Study Start date:
April 22, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Tung Shin Hospital

    Bukit Bintang, Kuala Lumpur 55100
    Malaysia

    Active - Recruiting

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