Wisconsin Ginseng for Decreasing Cancer Related Fatigue

PRIMARY OBJECTIVE:

I. To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks.

SECONDARY OBJECTIVES:

I. To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4, the Global Impression of Change at week 4 and 8, and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at week 4 and 8.

II. To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate (on a 0 to 10 scale) their toxicities experienced while on study.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive Western ginseng orally (PO) twice daily (BID) on days 1-56.

GROUP II: Patients receive placebo PO BID on days 1-56.

Inclusion criteria

• Age ≥ 18 years
• Has received or is receiving treatment for a solid-organ malignancy (not hematologic)
• History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet
• Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
• Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
• Life expectancy ≥ 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration)
• Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration)
• Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration)
• No clinical suspicion of hypothyroidism within 180 days prior to registration [if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) < 5 milli-international units per liter (mIU/L) is required]
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide informed consent

Exclusion criteria

• Any known hypersensitivity to ginseng
• Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed
• Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)
• Use of erythropoietic agents ≤ 6 months
• Uncontrolled hypertension on more than three occasions (diastolic blood pressure ≥ 100, systolic ≥ 160) measured ≤ 180 days prior to randomization
• Surgery that required general anesthetic ≤ 30 days prior to randomization
• Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), 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, guarana, or anything called an "adaptogen")
• Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor
• Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)