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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT02645175 |
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Date of registration:
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22/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue
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Scientific 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 |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02645175 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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Jacqueline Whang-Peng, MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director, Division of Cancer Center, Wan Fang Hospital, Taiwan |
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Name:
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Encarnacion Carlos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Oncology-Waco |
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Name:
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Joyce O'Shaughnessy, MD |
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Address:
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Email:
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Affiliation:
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Texas Oncology-Baylor Charles A. Sammons Cancer Center |
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Name:
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Wang Grace, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baptist Health Medical Group Oncology, LLC |
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Name:
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Danso Michael, MD |
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Address:
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Email:
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Affiliation:
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Virginia Oncology Associates |
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Name:
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Anderson Thomas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Oncology-Bedford |
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Name:
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Lee Jae, MD |
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Address:
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Email:
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Affiliation:
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Willamette Valley Cancer Institute and Research Center |
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Name:
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Tsai Michaela, MD |
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Address:
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Email:
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Affiliation:
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Minnesota Oncology Hematology, P.A. |
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Name:
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Smith II John, MD |
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Address:
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Email:
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Affiliation:
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Northwest Cancer Specialists, P.C. |
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Name:
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Taguchi Julie, MD |
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Address:
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Email:
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Affiliation:
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Sansum Clinic |
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Name:
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Fleischauer Scott, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Oncology-Arlington North |
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Name:
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Holmes Frankie, MD |
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Address:
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Email:
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Affiliation:
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Texas Oncology-Memorial City |
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Name:
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Houck William, MD |
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Address:
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Email:
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Affiliation:
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Shenandoah Oncology, P.C. |
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Name:
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Vukelja Svetislava, MD |
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Address:
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Email:
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Affiliation:
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Texas Oncology-Tyler |
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Name:
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Crane Gregory, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Kansas Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A patient is eligible for the study if all of the following apply:
1. 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
2. Histologically and/or cytologically confirmed HER2-negative breast cancer with
clinical evidence of recurrent or progressive metastatic disease
3. Patients may have measurable or nonmeasurable metastatic breast cancer.
4. Planning to begin a new chemotherapy regimen of the physician's choice
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
6. 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)
7. Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (=1%
cells positive for ER) by IHC
8. 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
9. Fatigue score of =5 on a 1-to-10 linear analog scale
10. Pain score of =4 on a 1-to-10 linear analog scale
11. Insomnia score of =4 on a 1-to-10 linear analog scale
12. If of childbearing potential, agrees to use reliable contraceptive method(s)
during participation in the study
13. Estimated life expectancy of at least 6 months
14. Has provided written informed consent and HIPAA authorization
Exclusion Criteria:
- Any patient meeting any of the exclusion criteria will be excluded from study
participation:
1. Has received radiotherapy or cytotoxic therapy within 3 weeks
2. Any uncontrolled infection
3. History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis,
scleroderma, or multiple sclerosis
4. History of known brain metastases; Screening for brain metastases is not
required
5. More than 4 prior cytotoxic chemotherapy regimens for metastatic disease
6. Requirement for ongoing systemic steroid therapy
7. 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.
8. 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
9. 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")
10. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to
comply with daily oral TW1025/placebo treatment
11. Uncontrolled thyroid disorder
12. Psychiatric disorder such as severe depression, manic depressive disorder,
obsessive compulsive disorder or schizophrenia (Defined per medical history)
13. Any other serious diseases/medical history that would limit the patient's
ability to receive study therapy as assessed by the investigator
14. Lactating, pregnant, or plans to be become pregnant
15. Has received an investigational agent within 4 weeks of entering this study
16. History of adverse reactions to any of the ingredients in TW1025.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Fatigue
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: TW1025
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Primary Outcome(s)
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Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline
[Time Frame: Baseline vs 9 weeks]
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Secondary Outcome(s)
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Number of Adverse Events (AEs)
[Time Frame: 1 year after discontinuation of study treatment]
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Secondary ID(s)
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TW1025-2014
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13145
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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