Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Musculoskeletal Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A quasi-experimental designMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 cance...

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.

Tracking Information

NCT #
NCT04843865
Collaborators
Not Provided
Investigators
Principal Investigator: Yang Mooi Lim Universiti Tunku Abdul Rahman (UTAR)