Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Breast Neoplasms

Syndrome

Pain

Musculoskeletal Pain

Breast Diseases

Skin Diseases

Muscular Diseases

Neurologic Manifestations

All Drugs and Chemicals

Aromatase Inhibitors

Participants received standardized Chinese Herbs treatment orally twice daily for 1 week.

Chinese Herbs

Chin Long Poo

King Keong Chung

Yang Mooi Lim

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.

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.

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

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

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

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.

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).

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.

The Depression Anxiety Stress Scales (DASS) is a self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. A short version, the DASS 21 scale consists of a list of 21 symptoms with 7 item per scale, each of which is to be rated on a four-point scale of how much you had that symptom in the last week from 'never' to 'most of the time'. In this study, stress will be determined by stress domain of DASS-21 which consists of 7 items.

The body constitution will be determined by Constitution in Chinese Medicine Questionnaire (CCMQ). It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.

* the minimum and maximum values: 0, 100
* higher scores mean a worse outcome.

The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).

The liver function of the patients will be determined by measuring the alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase.

Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.

Change in CRP (C-Reactive Protein) will be determined by laboratory examination.

Change in Progesterone will be determined by laboratory examination.

Change in Estradiol will be determined by laboratory examination.

The cytokines in serum samples of breast cancer patients will be detected by the Quantibody array, multiplexed sandwich enzyme-linked immunosorbent assay (ELISA) based quantitative array platform (Genomax technology) for quantitative measurement of cytokines in human serum. The unit of measurement for the cytokines is the same.

Universiti Tunku Abdul Rahman

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

Herbal and Botanical

Chinese Yam

All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer.

The patients will be offered the choice of taking the CH formula in capsules or sachets and given instructions about recommendations to improve palatability. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.

Chinese herbs formula: Shu Yu Wan

Thomas Jagoe, MD

The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC.

Patients with advanced NSCLC, in addition to their very poor chances of cure or extended survival, frequently suffer a range of different symptoms related to both their disease and its treatment. As a result there is a pressing need to develop more effective anti-cancer therapies and an imperative to enhance the effects of existing treatments and alleviate symptoms more effectively.

Increasing numbers of patients with cancer are using complementary medicine, including Chinese herbs (CH), and evidence is accumulating from a growing number of laboratory studies and clinical trials, that CH may exert beneficial effects for cancer patients in many ways.

The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the JGH. A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC.

This is a prospective, longitudinal cohort study of a 6-week clinical intervention with Chinese herbs in advanced (Stage 4) NSCLC patients All the active patients who have histologically or cytologically proven metastatic NSCLC with Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2 will be eligible to participate in the study. Quality of life will be assessed by FACT-L and Edmonton Symptom Assessment System (ESAS) questionnaires. Patient will be instructed to complete a diary each day to confirm adherence to treatment and to indicate the reason(s) that any doses were missed or treatment was stopped.

This is a feasibility study designed to see if the main study can be done.

A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC

A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)

Number of participants consented over the total number of approached for the study.

Functional Assessment of Cancer Therapy - Lung (FACT-L) is a 36-item self-assessment questionnaire that measures QOL over the past week in patients with lung cancer. The FACT-L is made up of five subscales of question rated on a five-point Likert scale and include physical well-being (PWB, range of scores is 0-28), social/family well-being (SWB, range of scores is 0-28), emotional well-being (EWB, range of scores is 0-24), functional well-being (FWB, range of scores is 0-28), and symptoms of lung cancer scale (LCS, range of scores is 0-36). For all subscales higher score is better. A total overall score (0-144). Alternative scoring includes the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, and Lung Cancer Subscales. Total score ranges from 0-92 with high score being better. The clinically meaningful changes of this measure is 6 points. Unit measure is scores on a scales.

The Physical well-being (PWB) subscale has 7 questions with the range of the score from 0 to 4 each. The range of the total score is 0 to 28. The higher the score the better the physical well-being. Effect size (ES) of this study based on magnitude difference of PWB scale of the FACT-L between two measures (baseline and 6 weeks). This ES will be used to calculate sample size in Phase 2 study

Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)

The Edmonton Symptom Assessment System (ESAS) is a valid and reliable assessment tool to assist in the assessment of common symptoms experienced by cancer patients including: sleep, well-being, pain, strength, appetite, nausea, vomiting, constipation, drowsiness, tiredness, shortness of breath, depression, anxiety, and distress. Each symptom is rated from 0 to 10 cm on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.

Lady Davis Institute

A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected CH formula in patients with stage 4 NSCLC at our center. Patients with stage 4 NSCLC were eligible if they had Eastern Cooperative Oncology Group performance status of 0-2 and had not used CHs. In addition, to ensure that no CH-related side effects were misattributed to chemotherapy, only patients who had completed at least one cycle of their current standard chemotherapy and were clinically stable were eligible. Patients who were not on treatment were also eligible if there was no plan to recommence the treatment within the next 6 weeks. To safeguard those who were perceived to be potentially at increased risk of side effects from CHs, patients with active brain metastases, abnormal liver function or those taking tyrosine kinase inhibitors, immunosuppressive drugs, anticonvulsant and anticoagulant medications were excluded.

A Single Arm, Prospective Study

All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.

Chinese Herbs Formula: Shu Yu Wan

Age at the time of enrollment treated as a continues variable

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Low (<19.5)

Normal (19.6-24.5)

High (>24.5)

Body mass index measured at the baseline and categorized as:

Low \<19.5 kg/m2 Normal 19.6-24.5 kg/m2 High \>24.6 kg/m2

Body Mass Index (BMI)

ECOG PS 0-1

ECOG PS 2-3

Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

Eastern Cooperative Oncology Group (ECOG) Performance Status

Ex/never smoker

Smoker

Smokers had a history of consuming at least 5 cigarettes a day in the last 2 years; Ex-smokers are those who quit smoking 2 or more years ago; Non-smoker are those who never smoke a cigarette during the life time. Fo purpose of this study participants categorized as ex/never smokers versus smokers

Smoking status

This is a small study in a single centre leading to small number of subjects Caveat: further randomized controlled study needed to confirm the safety and benefit of of CH formula.

Goulnar Kasymjanova

enrolled

refused

already taking some herbal supplement

Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks

Feasibility of Using CH for Full-scale Future Research

Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant

Physical well-being

Social well-being

Emotional well-being

Functional well-being

Lung cancer scale

Trial outcome index

The Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher scores is considered better.

Baseline

Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.

6 Weeks

Change in QOL From Baseline on the 36 Items Functional Assessment of Cancer Therapy - Lung (FACT-L) at the End of the Study (Week 6)

Physical Well-Being (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse

Physical Well-Being Scores at Baseline and 6 Weeks

Total number of reported adverse events (AE)

Grade 1 AEs

Grade 2 AEs

Related to CH fomula

Number of adverse events reported between baseline and 6 weeks

Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC

Sleep

Well-being

Strength

Appetite

Nausea

Vomiting

Constipation

Drowsiness

Tiredness

Shortness of breath

Depression

Anxiety

Distress

Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)

A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected Chinese herbs (CH) formula in patients with stage 4 non-small cell lung cancer (NSCLC). All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard of care. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for 6 weeks.

Chinese Herbs Formula

Overall Study

Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.

BZL101

Deborah Grady, M.D.

Charles Shapiro, MD

BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0

Best Overall Tumor Response - Investigator Assessment

Best Overall Tumor Response - Independent Radiology Assessment

Bionovo

Level 1

Level 2

Level 3

Level 4

Total

Age Continuous

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Mary Tagliaferri, MD

Elevated AST

Diarrhea

Fatigue

Pain-rib cage

Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)

Complete Response and Partial Response

Stable Disease

Progressive Disease

Unknown

Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)

Neoplasm Metastasis

Neoplastic Processes

Pharmaceutical Solutions

Aconite

Dietary Supplement:Experiment group:

Fructus Cnidii,Psoralea Corylifolin L.，monkshood

-Granules,Oral(add into the breast cancer postoperative prescription solution),A Pack(Fructus Cnidii 9g，Psoralea Corylifolin L. 15g，monkshood 9g),Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity

Breast Cancer Postoperative Prescription

-Water Decoction,Oral,200ml,Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity

Dietary Supplement:Contrast Group:

Breast Cancer Postoperative Prescription

-Water Decoction,Oral,200ml,Bid Days,3 Periods( a month is a period),Until progression/unacceptable toxicity

The purpose of this clinical research study is to learn if the clinical effects of combined Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OBJECTIVES:

* Evaluate the effect of the Chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis.
* Evaluate the effect of the Chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OUTLINE: This is a randomized,multicentric, placebo-controlled, double-blind study. Patients are dynamic randomized to one of two treatment arms.

* Arm I:Patients receive traditional Chinese medicine(trial drugs) and endocrine therapy for 3 months.
* Arm II:Patients receive placebo and endocrine therapy for 3 months. All patients will be followed up for another 3 months with the trial drugs and endocrine therapy.

According to the sample size estimate:There are 296 patients (148 per treatment arm)will be collected in this trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients	NCT04843865	Breast Cancer Musculoskeletal...	Chinese Herbs	18 Years -	Universiti Tunku Abdul Rahman
A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC	NCT02331394	Lung Cancer	Chinese herbs f...	18 Years -	Lady Davis Institute
A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer	NCT00454532	Metastatic Brea...	BZL101	18 Years -	Bionovo
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer	NCT02011880	Breast Cancer Bone Metastasis	Chinese Herbs	20 Years - 70 Years	Shanghai University of Traditional Chinese Medicine
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer	NCT02011880	Breast Cancer Bone Metastasis	Chinese Herbs	20 Years - 70 Years	Shanghai University of Traditional Chinese Medicine

Spots Global Cancer Trial Database for chinese herbs