TCM as an Adjuvant Treatment in Breast Cancer Patients

Launched by UNIVERSITI TUNKU ABDUL RAHMAN · Apr 9, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the use of traditional Chinese medicine, specifically Chinese herbs, as a complementary treatment for women with breast cancer who are experiencing muscle and joint pain. The goal is to see if these herbs can help reduce the side effects caused by standard cancer treatments, particularly in postmenopausal women with hormone-receptor positive breast cancer who are currently taking a medication called letrozole. Participants will need to have a certain level of ongoing pain and must have completed their initial cancer treatments, including surgery and chemotherapy.

To be eligible for this trial, women must be between the ages of 65 and 74, postmenopausal, and experiencing musculoskeletal pain that started or worsened after beginning letrozole. They should also be willing to take the prescribed Chinese herbs and participate in follow-up visits throughout the study. It's important to note that there are some restrictions, such as not having other serious health conditions or recent infections. If you or someone you know meets these criteria and is interested in participating, this trial could provide an opportunity to explore an alternative approach to managing discomfort during breast cancer treatment.

Gender

FEMALE

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)