NCT04843865

TCM as an Adjuvant Treatment in Breast Cancer Patients

A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universiti Tunku Abdul Rahman · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The previous studies have reported that adjuvant Chinese herbs therapy can improve the survival of breast cancer patients by alleviating the side effects of conventional treatments. Protein expression determines the phenotype of a patient that contributes to the onset of side effects in breast cancer patients caused by conventional treatment. Chinese herbs treatment will alleviate the treatment-related side effects by altering the protein expression in the patients. Associating changes in protein levels with the onset of side effects caused by conventional treatments could be used to identify clinically relevant diagnostic biomarkers. In addition, a set of proteome that is being expressed at diseased state will exhibit the phenotype that is also correlated to the TCM syndrome differentiation. Hence, this study aims to determine the proteome profile for the syndrome differentiation of breast cancer patients treated with adjuvant Chinese herbs for musculoskeletal pain. A quasi-experimental study with purposive sampling will be conducted on 30 breast cancer patients recruited from Tung Shin hospital. All participants will be invited to complete a structured questionnaire to collect their demographic information, pain score, syndrome element differentiation, quality of life, stress, body constitution and other relevant information, including cancer type, cancer stage, and cancer treatment. The questionnaires will be self-administered either at the outpatient waiting room or in the ward of the study hospital. Blood of the patients will be collected for determination of protein expression, biochemical markers and cytokines. The study is an in-point analysis where 2 time-points of data collection and analysis will be carried out at baseline, and immediate post Chinese herbs treatment. Informed consent will be obtained before participant enrolment according to a clinical trial protocol. Statistical differences for protein expression, biochemical markers, cytokines and mean pain score before and after Chinese herbs treatment will be compared using the paired-sample t test.

Conditions

• Breast Cancer
• Musculoskeletal Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chinese Herbs	Chinese Herbs

Timeline

• Start date: 2022-04-22
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-04-14
• Last updated: 2024-12-31

Locations

1 site across 1 country: Malaysia