RecruitingPhase 3

Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Phase III Study of Ginseng for Cancer Related Fatigue

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Wisconsin ginseng can reduce cancer-related fatigue, or strong tiredness. It compares ginseng with a placebo, a pill with no active treatment, in adults with cancer and significant 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Group 1: Have received or be receiving treatment for cancer in a solid organ.
  • Group 2: Have chronic lymphocytic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, or multiple myeloma. People in follow-up care within 5 years after finishing treatment for these blood cancers may also join.
  • Have an average fatigue score of at least 4 over the past 30 days. Scores for pain and trouble sleeping must each be 4 or less.
  • Be expected to live at least 6 months. Be able to care for yourself and be out of bed or a chair for at least half the day.
  • Meet blood count, liver, and kidney test limits using tests from the past 180 days. Limits differ by group. You cannot use a blood transfusion from the past 90 days to meet the hemoglobin limit; hemoglobin carries oxygen in blood.
  • Have no suspected low thyroid function in the past 180 days, or have a thyroid test result below the study's limit. If you could become pregnant, have a negative pregnancy test within 7 days before signing up.
  • Be able to answer study questions, with help if needed, and give informed consent to join.

Who can't join

  • Have a known allergy to ginseng, or use herbal or diet supplements sold for energy or fatigue.
  • Use medicines specifically for fatigue, diabetes medicines, warfarin, or an MAOI antidepressant. Antidepressants for other reasons are allowed if the dose has been stable for at least 30 days and will stay the same for 8 weeks. Medicines that help make red blood cells are not allowed within the past 6 months.
  • Have a mental health disorder listed by the study, such as poorly controlled depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia. Poor nutrition, an active infection, severe depression, or major lung or heart disease may also rule you out.
  • Have blood pressure readings with a top number of at least 160 or a bottom number of at least 100 on more than 3 occasions in the past 180 days. Surgery requiring medicine to put you fully asleep within the past 30 days also rules you out.
  • Have a cancer care provider who expects your cancer treatment plan to change during the next 8 weeks.
  • Be pregnant or breastfeeding, or be able to become pregnant but unwilling to use adequate birth control.
  • Group 2: Have stayed in the hospital for more than 24 hours in the past 2 months, expect a hospital stay for cancer treatment within the next 3 months, or be in another trial testing a treatment.
  • Group 2: Have ever had a stem cell transplant from a donor; had CAR-T cell treatment or a transplant using your own stem cells within 180 days; or started a T-cell engager within 3 months. CAR-T and T-cell engagers help immune cells fight cancer. Stable ongoing T-cell engager doses are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (15)

MN