The Effects of Ginseng on Cancer-Related Fatigue (NCT01375114) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
The Effects of Ginseng on Cancer-Related Fatigue
United States165 participantsStarted 2011-10-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. All patients with a histological diagnosis of cancer.
✓. 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).
✓. Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.
✓. Memorial delirium assessment scale \</= 13.
✓. Are 18 years or older.
✓. Hemoglobin level of \>/=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level \<9g/dL will be evaluated for treatment of anemia.
✓. Able to understand and sign the informed consent.
✓. No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment).
Exclusion criteria
✕. Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris).
✕. Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days.
✕. Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.