A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy with Ginseng for Patients on Treatment with Regorafenib
Study on Ginseng's Effect on Fatigue from Investigational Medication
Brief description of study.
The purpose of this study is to test whether ginseng can reduce the severity of the fatigue caused by regorafenib.
Detailed description of study
The purpose of this study is to assess fatigue with the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Patient-Reported Outcomes Measurement Information System (PROMIS) form for each group (Regorafenib = No Ginseng vs. Regorafenib + Ginseng) to determine if 2000 mg of American Ginseng for 8 weeks has an impact on the fatigue score.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: colon cancer
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Age: 18 years - 100 years
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Gender: All
This study investigates how ginseng affects tiredness in people taking an investigational medication. Fatigue, or extreme tiredness, is a common side effect of some treatments. The study aims to see if taking 2000 mg of American Ginseng for 8 weeks can make a difference in how tired people feel.
Participants will be divided into two study arms: one taking the investigational medication without ginseng and the other taking it with ginseng. The level of fatigue will be measured using special questionnaires designed to understand tiredness and its impact on daily life.
- Who can participate: Participants must meet certain health criteria to be eligible.
- Study details: Participants will either receive the investigational medication alone or with ginseng. Fatigue will be assessed using specific questionnaires. The study may involve a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
Interested in the study?
Select a study center that’s convenient for you, and get in touch with the study team.
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