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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02645175
• Other study ID #: TW1025-2014
• Secondary ID: 13145
• Status: Terminated
• Phase: Phase 2
• First received: December 22, 2015
• Last updated: October 20, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Meriyana Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Metastatic Breast Cancer

Intervention

Dietary Supplement:
• TW1025
20ml, 3 times per day (daily dose: 60 ml)
• Placebo
20ml, 3 times per day (daily dose: 60 ml)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Meriyana Bio Inc.	US Oncology Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fatigue Scores at Baseline vs at 18-weeks	Change in fatigue scores at 18 weeks post-supplement initiation and other on-treatment time points compared with baseline assessed by using the FACIT Fatigue subscale	Baseline vs 18-weeks	No
Other	Change in Sleepiness Scores	Change in Daytime sleepiness scores, assessed using the Epworth Sleepiness Scale (ESS)	Baseline vs 9 weeks	No
Other	Change in Quality of Life Scores	Change in Quality of life scores, assessed using the Quality of Life Linear Analog Scale (QOL-LAS)	Baseline vs 9 weeks	No
Other	Change in Overall Impression	The Subject Global Impression of Change is a 7-point instrument in which the patient rates the change in their overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials. Patients will be asked to fill out the Global Impression of Change scale at week 9 after starting study therapy only.	9 weeks	No
Other	Levels of C-reactive protein in blood	C-reactive protein levels will be measured at baseline, and at weeks 9 and 18 following initiation of dietary supplement.	baseline vs 9-weeks vs 18-weeks	No
Other	Change in Gene Expression	Change in Whole blood gene expression profiles will be assessed using the NanoString® human immunology and the human inflammation gene panels at baseline and at weeks 9 and 18 of dietary supplementation. RNA-Seq or other methodologies may also be utilized to evaluate cytokine and immune cell signaling pathways	Baseline vs 9-weeks vs 18-weeks	No
Primary	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	No
Secondary	Number of Adverse Events (AEs)	Adverse events (side effects) in each arm will be counted and compared	1 year after discontinuation of study treatment	Yes

External Links

•   Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
•   Safety and Efficacy of Tien-Hsien Liquid Practical in Patients with Refractory Metastatic Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IIa Trial