Tests Wisconsin ginseng against placebo for cancer-related fatigue

Trial details

Who runs it

Mayo Clinic

Trial code

NCT06395441

Record updated

20 October 2026

Original description

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.Read full original descriptionShow less

Phase III Study of Ginseng for Cancer Related Fatigue

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

Inclusion: 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.

Exclusion: 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; 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); 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; 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.

ClinicalTrials.gov NCT06395441