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

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.

Conditions

• Metastatic Breast Cancer
• Fatigue

Interventions

DIETARY_SUPPLEMENT

TW1025

20ml, 3 times per day (daily dose: 60 ml)

DIETARY_SUPPLEMENT

Placebo

20ml, 3 times per day (daily dose: 60 ml)

Sponsors & Collaborators

• US Oncology Research

  collaborator INDUSTRY

• Meriyana Bio Inc.

  lead INDUSTRY

Principal Investigators

• Joyce O'Shaughnessy, MD · Texas Oncology-Baylor Charles A. Sammons Cancer Center

• Jacqueline Whang-Peng, MD. · Director, Division of Cancer Center, Wan Fang Hospital, Taiwan

• Anderson Thomas, MD · Texas Oncology-Bedford

• Danso Michael, MD · Virginia Oncology Associates

• Encarnacion Carlos, MD · Texas Oncology-Waco

• Fleischauer Scott, MD · Texas Oncology-Arlington North

• Taguchi Julie, MD · Sansum Clinic

• Wang Grace, MD · Baptist Health Medical Group Oncology, LLC

• Holmes Frankie, MD · Texas Oncology-Memorial City

• Houck William, MD · Shenandoah Oncology, P.C.

• Crane Gregory, MD · The University of Kansas Cancer Center

• Tsai Michaela, MD · Minnesota Oncology Hematology, P.A.

• Vukelja Svetislava, MD · Texas Oncology-Tyler

• Lee Jae, MD · Willamette Valley Cancer Institute and Research Center

• Smith II John, MD · Northwest Cancer Specialists, P.C.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2018-12-31

Completion

2018-12-31