Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Korábbi kezelés

• 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
• 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
• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential who are unwilling to employ adequate contraception. (e.g., hormonal methods, barrier methods, intrauterine device, abstinence)
• GROUP 2 PARTICIPANTS: Patients who have been hospitalized (> 24 hours) in the previous 2 months or who will require hospitalization (for anti-cancer therapy) within the next 3 months
• GROUP 2 PARTICIPANTS: Prior allogeneic transplant
• GROUP 2 PARTICIPANTS: Chimeric antigen receptor T cell (CAR-T), or autologous transplant within the last 180 days

Más betegség

• Any known hypersensitivity to ginseng
• Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)
• Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), as they could impact fatigue
• Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)

Laborértékek

• Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor
  • Examples of antidiabetic drugs include: Insulin, sulfonylureas, sodium-glucose co-transporter subtype 2 (SGLT2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonists/dual incretin agonists, and related agents

Egyéb

• Use of erythropoietic agents ≤ 6 months
• 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")
• GROUP 2 PARTICIPANTS: T-cell engager initiation within the last 3 months (patients on stable maintenance dosing are permitted)
• GROUP 2 PARTICIPANTS: Enrolled in another interventional clinical trial

• Age ≥ 18 years
• GROUP 1 PARTICIPANTS: Has received or is receiving treatment for a solid-organ malignancy (does not apply to Group 2)
• GROUP 2 PARTICIPANTS: Diagnosis of one of the following hematologic malignancies: Chronic lymphocytic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma (NHL), multiple myeloma, or survivorship care after completion of therapy for one of the above hematologic malignancies (within 5 years of completion of therapy)
• 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
• GROUP 1 PARTICIPANTS: The following laboratory values obtained ≤ 180 days prior to registration (does not apply to hematologic malignancies)
  • 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 upper limit normal (ULN)
  • Creatinine ≤ 1.5 x ULN
• GROUP 2 PARTICIPANTS: The following laboratory values obtained ≤ 180 days prior to registration (does not apply to solid-organ malignancies):
  • Hemoglobin ≥ 8.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion)
  • Platelet count ≥ 50,000 cells/mm\^3
  • Absolute neutrophil count ≥ 1000 cells/mm\^3
  • 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 exists, a documented thyroid stimulating hormone [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