Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors

Inclusion Criteria:

• Histologic or cytologic proven breast cancer or colon cancer (stage I, II or III)
• Treated with chemotherapy and surgery
• Treatment has been completed (except hormone therapy) for >= 90 days prior toregistration
• No known evidence of disease
• Men or women with a history of CRF as defined by a score >= 4 on the numeric analoguescale (0 ? 10) (Eligibility Question Fatigue Scale)
• Presence of CRF >= 30 days prior to registration
• Hemoglobin >= 11.0 g/dL obtained =< 180 days prior to registration
• Serum glutamic-oxaloacetic transaminase (SGOT) =< 1.5 x upper limit of normal (ULN)obtained =< 180 days prior to registration
• Creatinine =< 1.2 X ULN obtained =< 180 days prior to registration
• Ability to complete questionnaire(s) in English by themselves or with assistance
• Provide written informed consent
• Willing to return to enrolling institution for follow-up of the study and optionalcrossover (if applicable)
• Willing to provide blood samples for correlative research purposes
• Negative pregnancy test done =< 7 days prior to registration, for women ofchildbearing potential only
• CROSSOVER RE-REGISTRATION - INCLUSION CRITERIA
• Treatment cannot begin prior to re-registering to the crossover phase and will ideallybegin =< 7 days after registration for the crossover phase

Exclusion Criteria:

• Hypersensitivity to ginseng
• Use of ginseng capsules for fatigue, within the last 12 months
• Uncontrolled hypertension >= 2 times as noted in medical history (diastolic bloodpressure > 100, systolic > 160) =< 90 days prior to registration
• Currently using any other pharmacologic agent to specifically treat fatigue includingpsychostimulants, antidepressants, etc., although antidepressants used to treat itemsother than fatigue (such as hot flashes) are allowed if the patient has been on astable dose for >= 30 days prior to registration and plans to continue for >= 30 daysafter registration; erythropoietin agents to treat anemia are allowed
• Known brain metastasis or primary central nervous system (CNS) malignancy
• Chronic oral or intravenous systemic steroid use (defined as being used on a regularbasis or who have a problem that has required ongoing use of steroids in the last 180days for greater than 7 days)
• Diabetes (defined by being on oral hypoglycemics or insulin)
• Psychiatric disorder such as severe depression, manic depressive disorder, obsessivecompulsive disorder or schizophrenia; (defined per medical history)
• Major surgery =< 28 days prior to registration
• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequatecontraception
• Treatable causes of fatigue have not been ruled out, at least by history and examcriteria, by the treating provider, such as uncontrolled pain, hypothyroidism, orinsomnia; NOTE: if these are considered to be the primary cause for the patient?sfatigue then the patient is not eligible for this trial
• Patients with pain requiring opioid pain medication; NOTE: over the counter analgesicssuch as Tylenol or ibuprofen are allowed
• New use of Ambien and/or other benzodiazepines =< 30 days prior to registration
• New use of sleep aids including melatonin =< 30 days prior to registration
• Use of full anticoagulant doses of coumadin or heparin (exception: 1 mg/day ofcoumadin for preventing catheter clots is allowed)
• Use of monoamine oxidase inhibitors (MAOI) inhibitors
• Patients scoring greater than 4 on a 0 to 10 scale with regard to sleep troubles orpain
• Patients planning to start any type of cancer therapy during the 8 week, double blind,course of the study, once randomized on the study
• Patients with malnutrition, active infection, significant pulmonary disease andcardiovascular disease as determined by the physician as they could impact fatigue
• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, high doses ofcaffeine, guarana, or anything called an ?adaptogen?)
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgmentof the investigator, would make the patient inappropriate for entry into this study orinterfere significantly with the proper assessment of safety and toxicity of theprescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements
• Receiving any other investigational agent which would be considered as a treatment forthe primary neoplasm
• History of myocardial infarction =< 180 days prior to registration, or congestiveheart failure requiring use of ongoing maintenance therapy for life-threateningventricular arrhythmia