The Effects of Ginseng on Cancer-Related Fatigue
Condition: Advanced Cancers; Solid Tumors
MeSH terms: Fatigue
Intervention: Panax Ginseng; Placebo; Questionnaires
Intervention description: 400 mg by mouth twice daily from Day 1-29.; Placebo by mouth twice daily for 4 weeks.; Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Solid Tumors; Cancer related fatigue; CRF; Panax ginseng; Placebo; Sugar pill; Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F; Quality of life; QOL; FACT-G; Hospital Anxiety and Depression Inventory; Neurocognitive function; SDMT; Global Symptom Evaluation; GSE

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients with a histological diagnosis of cancer.

          2. 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).

          3. Describe fatigue as being present every day for most of the day for a minimum of 2
             weeks.

          4. Memorial delirium assessment scale </= 13.

          5. Are 18 years or older.

          6. 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.

          7. Able to understand and sign the informed consent.

          8. No concurrent use of chronic systemic steroids (defined as currently on more than 1
             week of treatment).

          9. Controlled pain and depression symptoms, if present ( defined as no change in the
             Morphine equivalent dose of 30% or change in the dose of antidepressant medication in
             the past 2 weeks)

         10. Patients should have a Zubrod </= 2.

         11. All patients who are receiving chemotherapy and/or radiation therapy are eligible for
             study if they have completed at least one cycle of chemotherapy or targeted therapy,
             or > 1 week of radiation therapy, and if they have been approved to go on study by
             their primary oncologist. The PI/designated research staff of this study will obtain
             and document approval from the primary oncologist and principal investigator of the
             clinical trial in case the patient is on another clinical trial as referenced in the
             patient's study documents.

         12. Negative pregnancy test for women of childbearing potential, as defined by intact
             uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test
             to be performed no greater than 14 days prior to consent in study. In cases of women
             with elevated b-HCG, these candidates will be eligible to participate so long as the
             level of b-HCG is not consistent with pregnancy. Women of childbearing potential need
             to be on or use contraception, or be abstinent during the study period. Their male
             partners must also use contraception (condom) or maintain abstinence. Birth controls
             specifications: Women who are able to become pregnant must use birth control during
             the study and for 30 days after the last ginseng/placebo dose. Acceptable forms of
             birth control include barrier methods (such as condom or diaphragm) with spermicide.

        Exclusion Criteria:

          1. Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their
             constituents (history of arrhythmias, agitation, or motor tics, or severe angina
             pectoris).

          2. Currently taking ginseng, methylphenidate or modafinil or have taken it within the
             previous 10 days.

          3. Inability to complete the baseline assessment forms or to understand the
             recommendations for participation in the study.

          4. Currently with a diagnosis of major depression, manic depressive disorder,
             obsessive-compulsive disorder, or schizophrenia).

          5. Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically
             significant by the PI).

          6. Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone,
             MAOIs, clonidine and tricyclic antidepressant drugs

          7. Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not
             being monitored by their primary care physician.

          8. No concurrent full dose anticoagulant therapy. </= 1 mg/day of coumadin for preventing
             catheter clots allowed.

          9. History of hepatitis A, B and C.

         10. Women who are nursing.