NCT06395441 Wisconsin Ginseng for Decreasing Cancer Related Fatigue
| NCT ID | NCT06395441 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mayo Clinic |
| Condition | Malignant Solid Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 222 participants in total. It began in 2024-08-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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 * 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 * Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period) * 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 * 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
Contact & Investigator
Daniel S. Childs, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06395441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Solid Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06395441 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 222 participants.
Is NCT06395441 currently recruiting?
Yes, NCT06395441 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06395441 trial being conducted?
This trial is being conducted at Albert Lea, United States, Bemidji, United States, Brainerd, United States, Deer River, United States and 11 additional locations.
Who is sponsoring the NCT06395441 clinical trial?
NCT06395441 is sponsored by Mayo Clinic. The principal investigator is Daniel S. Childs, MD at Mayo Clinic in Rochester. The trial plans to enroll 222 participants.