Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic breast cancer patients receiving chemotherapy.

Detailed Description
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The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive HER2-negative metastatic disease and planning to begin a chemotherapy regimen of physician's choice for HER2-negative MBC who have evidence of fatigue. An add-on study design to assess the superiority of TW1025 over placebo will be utilized in this study to evaluate whether TW1025 can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety Profile and Ability of TW1025 to Decrease Fatigue

Conditions
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Metastatic Breast Cancer, Fatigue

Intervention / Treatment
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* Dietary Supplement: TW1025
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient is eligible for the study if all of the following apply: Female patients at least 18 years of age for study sites in the United States and 20 to 80 years old (inclusive) for study sites in Taiwan Histologically and/or cytologically confirmed HER2-negative breast cancer with clinical evidence of recurrent or progressive metastatic disease Patients may have measurable or nonmeasurable metastatic breast cancer. Planning to begin a new chemotherapy regimen of the physician's choice Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 HER2-negative disease per College of American Pathologists (CAP) guidelines (immunohistochemistry (IHC) 0, 1+, or if 2+ fluorescence in-situ hybridization (FISH)-negative ratio < 2.0) Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (≥1% cells positive for ER) by IHC Adequate bone marrow function (absolute neutrophil count ≥ 1,500 /µL, hemoglobin count ≥ 8 g/dL, and platelet count > 100,000/µL), total serum bilirubin < 1.5 mg/dL and SGOT/SGPT less than 5-times the upper limit of normal if liver metastases are present or < 2.5-times the upper limit of normal if no liver metastases, and serum creatinine < 1.5 mg/dL Fatigue score of ≥5 on a 1-to-10 linear analog scale Pain score of ≤4 on a 1-to-10 linear analog scale Insomnia score of ≤4 on a 1-to-10 linear analog scale If of childbearing potential, agrees to use reliable contraceptive method(s) during participation in the study Estimated life expectancy of at least 6 months Has provided written informed consent and HIPAA authorization Exclusion Criteria: Any patient meeting any of the exclusion criteria will be excluded from study participation: Has received radiotherapy or cytotoxic therapy within 3 weeks Any uncontrolled infection History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma, or multiple sclerosis History of known brain metastases; Screening for brain metastases is not required More than 4 prior cytotoxic chemotherapy regimens for metastatic disease Requirement for ongoing systemic steroid therapy Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc. Note: Antidepressants used to treat items other than fatigue (such as depression or hot flashes) are allowed if the patient has been on a stable dose for ≥ 3 months and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed. Pain requiring long-acting continuous release narcotic pain medication; however, short-acting opioids (oxycodone, hydrocodone), tramadol, and over the counter analgesics such as acetaminophen or NSAIDs are allowed Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an adaptogen) Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral TW1025/placebo treatment Uncontrolled thyroid disorder Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (Defined per medical history) Any other serious diseases/medical history that would limit the patient's ability to receive study therapy as assessed by the investigator Lactating, pregnant, or plans to be become pregnant Has received an investigational agent within 4 weeks of entering this study History of adverse reactions to any of the ingredients in TW1025.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TW1025<br>TW1025 oral solution, 20ml, 3 times per day (daily dose: 60 ml) | Dietary Supplement: TW1025<br>* 20ml, 3 times per day (daily dose: 60 ml)<br>* Other names: Linease oral solution;|
| Placebo Comparator: Placebo<br>TW1025 oral solution matched placebo, 20ml, 3 times per day | Dietary Supplement: Placebo<br>* 20ml, 3 times per day (daily dose: 60 ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline | Change in fatigue scores at 9 weeks post-initiation of supplementation with TW1025/Placebo compared with baseline, assessed by using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale | Baseline vs 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Adverse events (side effects) in each arm will be counted and compared | 1 year after discontinuation of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paclitaxel, docetaxel, vinorelbine, eribulin