Using Chinese herbs to help breast cancer patients with pain from treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.