Using Chinese herbs to help breast cancer patients with pain from treatment
A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients
This study is testing whether Chinese herbs can help postmenopausal women with hormone-receptor positive breast cancer feel less pain from their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universiti Tunku Abdul Rahman Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bukit Bintang, Kuala Lumpur) |
| Trial ID | NCT04843865 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Chinese herbs as an adjuvant treatment for postmenopausal women with hormone-receptor positive breast cancer who experience musculoskeletal pain due to letrozole. It aims to assess how these herbs can alleviate side effects by altering protein expression related to the patient's condition. Participants will complete questionnaires to provide demographic information, pain scores, and quality of life metrics. The study will analyze the proteome profiles to identify potential biomarkers associated with treatment-related side effects.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with stage 2 to 3 hormone-receptor positive breast cancer currently taking letrozole and experiencing musculoskeletal pain.
Not a fit: Patients who are pregnant, nursing, or have not completed their cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related pain and improve the quality of life for breast cancer patients.
How similar studies have performed: Previous studies have shown that adjuvant Chinese herbs can improve survival and alleviate side effects in breast cancer patients, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bukit Bintang, Kuala Lumpur
- Tung Shin Hospital — Bukit Bintang, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Yang Mooi Lim — Universiti Tunku Abdul Rahman (UTAR)
- Study coordinator: Chin Long Poo
- Email: athrunjoe@gmail.com
- Phone: 0178853596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.