Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID04843865

A Systemic Study of Traditional Chinese Medicine as Adjuvant Treatment for Breast Cancer Patients

Led by Universiti Tunku Abdul Rahman · Updated on 2024-12-31

30

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the use of traditional Chinese herbs as an additional treatment for postmenopausal women with hormone-receptor positive breast cancer who experience musculoskeletal pain related to their conventional treatment. This study aims to see how Chinese herbs might reduce side effects by changing protein expressions connected to treatment symptoms and traditional Chinese medicine syndrome patterns. The research also seeks to identify proteins that could serve as diagnostic markers for these treatment side effects. Participants will receive prescribed Chinese herbs as a dietary supplement alongside their standard care, including letrozole therapy. The study involves collecting data at two points: before starting the Chinese herbs and immediately after one week of treatment. During this time, researchers will gather blood samples to analyze protein levels, biochemical markers, and cytokines, and participants will complete questionnaires assessing pain, quality of life, stress, and other health-related factors. Participants will be closely monitored for adherence to the treatment and changes in symptoms. Pain levels and protein expressions will be compared before and after the herbal treatment using statistical tests. The study includes a follow-up period and requires participants to communicate effectively and consent to all procedures. Overall, the study duration involves baseline assessment and immediate evaluation following one week of herbal therapy.

CONDITIONS

Official Title

TCM as an Adjuvant Treatment in Breast Cancer Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 54 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
Not Eligible

You will not qualify if you...

  • Pregnant or nursing woman or woman of childbearing potential without effective method of birth control
  • Patients who default subsequent follow-up or have irregular follow-up
  • Patients involved in other studies at the same time
  • History of non-compliance to medical regimen or unwilling/unable to comply with protocol
  • Bedridden and/or cancer metastasis to bone or lung
  • Concurrent infection requiring intravenous antibiotics
  • History of allergy to Chinese herbs
  • Previously received Chinese herbs for AI-induced musculoskeletal symptoms
  • Received Chinese herbs within one month prior to study entry
  • Current use of steroids or narcotics for pain relief within the past 2 weeks
  • Acute onset of chronic illness or acute disease in the past month or pre-existing chronic diseases
  • Patients with severe illness or metastatic disease such as poorly controlled hypertension, hypothyroidism, diabetes mellitus, liver diseases, osteoarthritis, rheumatoid arthritis, gout or neuropathic arthropathy, autoimmune or inflammatory joint disease, bone fracture, stroke

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Trial Site Locations

Total: 1 location

1

Tung Shin Hospital

Bukit Bintang, Kuala Lumpur, Malaysia, 55100

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Research Team

C

Chin Long Poo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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