Wisconsin Ginseng for Decreasing Cancer Related Fatigue
- Conditions
- Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
- Registration Number
- NCT06395441
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria:<br><br> - Age = 18 years<br><br> - History of cancer-related fatigue as defined by an average score = 4 over the past<br> 30 days on the numeric analogue scale. Patients can answer questions orally rather<br> than completing worksheet<br><br> - Baseline control of insomnia: Insomnia = 4 on Linear Analogue Scale. Patients can<br> answer questions orally rather than completing worksheet<br><br> - Baseline control of pain: Pain = 4 on Linear Analogue Scale. Patients can answer<br> questions orally rather than completing worksheet<br><br> - Life expectancy = 6 months<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2<br><br> - Hemoglobin = 10.0 g/dL (patients must not have been transfused in the preceding 90<br> days to meet this criterion) (= 180 days prior to registration)<br><br> - Alanine aminotransferase (ALT) or aspartate transaminase (AST) = 3 x upper limit<br> normal (ULN) (= 180 days prior to registration)<br><br> - Creatinine = 1.5 x ULN (= 180 days prior to registration)<br><br> - No clinical suspicion of hypothyroidism within 180 days prior to registration [if<br> clinical suspicion of hypothyroidism exists, a documented thyroid stimulating<br> hormone (TSH) < 5 milli-international units per liter (mIU/L) is required]<br><br> - Negative pregnancy test done = 7 days prior to registration, for persons of<br> childbearing potential only<br><br> - Ability to complete questionnaire(s) by themselves or with assistance<br><br> - Provide informed consent<br><br>Exclusion Criteria:<br><br> - Any known hypersensitivity to ginseng<br><br> - Currently using any other pharmacologic agents to specifically treat fatigue<br> including psychostimulants or antidepressants. Note: Antidepressants used to treat<br> items other than fatigue (such as hot flashes or depression) are allowed if the<br> patient has been on a stable dose for = 30 days and plan to continue such for 8<br> weeks. Exercise is allowed<br><br> - Psychiatric disorder such as poorly controlled depression, manic depressive<br> disorder, obsessive compulsive disorder, or schizophrenia (defined per medical<br> history)<br><br> - Use of erythropoietic agents = 6 months<br><br> - Uncontrolled hypertension on more than three occasions (diastolic blood pressure =<br> 100, systolic = 160) measured = 180 days prior to randomization<br><br> - Surgery that required general anesthetic = 30 days prior to randomization<br><br> - Malnutrition, active infection, severe depression, or significant pulmonary disease<br> and cardiovascular disease (as determined by the attending clinician), as they could<br> impact fatigue<br><br> - Use of any over the counter herbal/dietary supplement marketed for fatigue or energy<br> (for example, products containing any type of ginseng, Rhodiola rosea, guarana, or<br> anything called an adaptogen)<br><br> - Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor<br><br> - Treating provider anticipates a change to the anti-cancer treatment program in the<br> next 8 weeks (i.e., the intervention period)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in fatigue
- Secondary Outcome Measures
Name Time Method Change in fatigue;Percentage of patients who perceive moderate to very much better fatigue;Incidence of adverse events