A new Hoosier Cancer Research Network study is evaluating whether ginseng can help lessen fatigue in patients treated with regorafenib.

The study, known as GI14-191, builds on earlier research that showed daily use of American ginseng significantly decreased the level of fatigue experienced by cancer patients undergoing treatment. GI14-191 focuses on patients receiving regorafenib for colorectal cancer. The study is currently open to accrual at Wake Forest Baptist Health in Winston-Salem, N.C., with additional sites expected to open in the near future.

The U.S. Food and Drug Administration approved regorafenib in 2012 for the treatment of patients with metastatic colorectal cancer (mCRC) who were previously treated for their disease. Regorafenib was shown to have statistically significant benefit in overall survival and progression-free survival in patients randomly assigned to receive the drug. Yet nearly 50 percent of the treatment group experienced fatigue.

“We have made a lot of progress in finding new treatments for patients with gastrointestinal cancers,” said the study’s sponsor-investigator, Angela Alistar, MD (pictured), of Wake Forest Baptist Health. “As much as we focus on developing treatments that shrink tumors and have great responses, we have to be mindful of what these therapies do to our patients’ quality of life.”

For Dr. Alistar, the study is about more than just answering a scientific question; it is about seeking the best possible care for her patients. “As much as I want my patients to live longer, I also want them to be able to maintain a similar level of activity to what they had before — being able to go to that wedding, going to the gym, or being able to tolerate treatments better,” she said.

GI14-191 will enroll about 90 people who will be randomly assigned by a computer to one of two treatment groups. Group 1 will receive ginseng, and Group 2 will not receive ginseng. Study participants have a 2 in 3 chance of being assigned to the ginseng group. There is no placebo in this study.

Patients who enroll in the study must have stage IV colorectal cancer and be candidates for regorafenib treatment. Additional eligibility criteria must be met.

For more information about this study, including full eligibility requirements, visit clinicaltrials.gov (study #NCT02581059).

Funding support for this trial is provided by Bayer HealthCare Pharmaceuticals, Inc.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 160 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 5,000 subjects have participated in Hoosier Cancer Research Network clinical trials.