TCM as an Adjuvant Treatment in Breast Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversiti Tunku Abdul Rahman

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chinese Herbs

    Dietary supplement

    Chinese Herbs

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Chinese HerbsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the study (Adherence)

The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.

Time frame
Immediate post 1 week of Chinese Herbs intervention

Secondary outcomes

1

Feasibility of the study (Dropout rate)

The feasibility will be assessed by dropout rate of the patients.

Time frame
Immediate post 1 week of Chinese Herbs intervention
2

Change in the pain score

The pain score of breast cancer patients will be assessed by Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a validated and reliable tool used to assess the severity or intensity of pain on scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean a worse outcome.

Time frame
Baseline and immediate post 1 week of Chinese Herbs intervention
3

Change in Syndrome element differentiation

Syndrome Element Differentiation rating scale will be used to determine the syndrome element differentiation of the patients. Syndrome Element Differentiation rating scale can quantify the syndrome elements of this patient based on the clinical manifestations. The quantitative output weight values of syndrome elements are acquired from clinical input data based on the severity and frequency of each sign and symptom. Based on the quantitative output value, the syndrome elements can then be categorized into four levels of health state or severity: normal (\<70), mild (≥ 70 to \<100), moderate (≥100 to \<150), and severe (≥ 150).

Time frame
Baseline and immediate post 1 week of Chinese Herbs intervention
4

Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)

The quality of life will be assessed by the WHO-BREF questionnaire in this study. The WHOQOL-BREF instrument comprises 26 items, measuring the following broad domains: physical health, psychological health, social relationships, and environment, with scores ranging from 0 to 100. The four domain scores denote an individual's perception of the quality of life in each domain. Domain scores are scaled in a positive direction in which higher scores denote a higher quality of life. * the minimum and maximum values: 0, 100 * higher scores mean a better outcome.

Time frame
Baseline and immediate post 1 week of Chinese Herbs intervention

Other outcomes

Sponsors and contacts

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