The Effects of Ginseng on Cancer-Related Fatigue

Solid Tumors Clinical Trial

Official title: The Effects of Ginseng on Cancer-Related Fatigue

Status Active, not recruiting

Clinical Trial Summary

The goal of this clinical research study is to learn if panax ginseng (commonly called ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood changes in patients with cancer. The safety of ginseng will also be studied.

Clinical Trial Description

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 before.

Study Visits:

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. ;

Related Conditions & MeSH terms

• Advanced Cancers
• Fatigue
• Solid Tumors

• NCT number: NCT01375114
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2011
• Completion date: October 31, 2025