Clinical Trials

Inclusion Criteria:

• Age ≥18 years.
• History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale (Appendix II, Question 1.). Patients can answer questions orally rather than completing worksheet.
• Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale (Appendix II, Question 2.).  Patients can answer questions orally rather than completing worksheet.
• Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale (Appendix II, Question 3.).  Patients can answer questions orally rather than completing worksheet.
• Life expectancy ≥ 6 months.
• ECOG Performance Status (PS) 0, 1 or 2 (Appendix I).
•  The following laboratory values obtained ≤ 180 days prior to registration:
• • Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion);
  • Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x ULN;
  • Creatinine ≤ 1.5 x ULN.
• No clinical suspicion of hypothyroidism within 180 days prior to registration (if clinical suspicion of hypothyroidism exits, a documented TSH < 5 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 (ie, the intervention period).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/06/24. Questions regarding updates should be directed to the study team contact.