The Effects of Ginseng on Cancer-Related Fatigue
The Study Supplement:
Ginseng is an herbal supplement that may affect people's energy level, especially during
times of fatigue or stress. Many people have used ginseng, but its level of effectiveness
and safety has not been clearly studied. In this study, researchers will use questionnaires
and other tests to study how ginseng may affect cancer-related fatigue.
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a dose
of the study drug(s), depending on when you join the study. The first 30 participants will
take part in Part 1 of the study. Participants in Part 1 will take ginseng by mouth, in
capsule form, every day for 29 days. You will take it 2 times a day (morning and afternoon),
and will swallow a total of 2 capsules each day.
If you enroll on this study after the first 30 participants, you will take part in Part 2 of
the study. Participants in Part 2 will be randomly assigned (as in the flip of a coin) to 1
of 2 groups:
- Group 1 will take a placebo for 29 days. A placebo is not a drug. It looks like the
study drug but is not designed to treat any disease or illness. It is designed to be
compared with a study drug to learn if the study drug has any real effect. If you are
assigned to this group, you may be able to take ginseng later, in the second part of
the study (described below).
- Group 2 will take ginseng for 29 days, as the Part 1 group did.
You will have an equal chance of being assigned to either group. Neither you nor the study
staff will know which group you are in. However, if needed for your safety, the study staff
will be able to find out what you are receiving.
Both groups in Part 2 will take ginseng or placebo by mouth, every day for 29 days. You will
take it 2 times a day (morning and afternoon), 2 capsules each day.
After your Day 29 ginseng or placebo dose, if you tolerated the doses well, the study doctor
may decide you can take ginseng from Days 29-57, following the same dosing schedule you had
On Day 15 (± 3 days), Day 29 (± 3 days), Day 36 (+/- 3 days) and Day 57 (± 3 days), you will
fill out questionnaires about the symptoms you may be having, such as fatigue, mood,
depression, anxiety, nausea, appetite problems, sleep problems, and your overall sense of
well-being. This should take about 30 minutes. You will also be asked about any side
effects you may be having. You will also perform a medication review. If you cannot come to
the clinic on these days, the research nurse will call and ask you the questions over the
phone. The strength and stamina of your arm muscle will be measured only if you come to the
clinic. It will not be measured if you are contacted over the phone. Blood (about 1
tablespoon) will be drawn for routine tests on Day 15 (± 3 days), Day 29 (± 3 days) and Day
57 (± 3 days).
The 6-minute walk test will be performed on baseline, Day 15 (± 3 days), Day 29 (± 3 days),
and Day 57 (± 3 days).
On Day 8 (± 3 days), Day 21 ( +/- 3 days), Day 36 (± 3 days), and Day 43 (± 3 days), the
research nurse will call and ask about the symptoms and side effects you may be having. You
will also perform a medication review. This should take about 30 minutes.
If you are unable to return to MD Anderson for your routine blood draw, your local doctor
can draw the blood and your results will be sent to MD Anderson.
You blood will be drawn weekly if you are taking coumadin to check to see how fast your
blood clots. Liver function tests will also be performed every 2 weeks if you have
metastasis to your liver or are on medication such as acetaminophen statins.
Length of Participation:
If you are the among the first thirty patients you will be assigned to receive/take ginseng
at the beginning of the study for a total 29 days followed by up to 28 days of ginseng, if
the study doctor thinks it is in your best interest. If you are not among the first thirty
patients you may receive up to 29 days of ginseng/placebo followed by up to 28 days of
ginseng, if the study doctor thinks it is in your best interest. Ginseng/placebo will be
stopped early if intolerable side effects occur.
If your main doctor for cancer approves, you may take ginseng after Day 57 (outside of the
study) if you tolerated it well.
This is an investigational study. Ginseng is commercially available. Giving ginseng to
patients with cancer and fatigue is being done for research purposes only.
Up to 158 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Efficacy of Panax Ginseng in Reducing Cancer Related Fatigue
Fatigue assessment measured by the Functional Assessment of Cancer Therapy- Fatigue (FACIT-F) subscale where rate fatigue on a numerical scale during the previous 24 hours as >/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue).
Baseline and after 4 weeks
Sriram Yennurajalingam, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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