Malignant Solid Neoplasm study: American Ginseng
Official title Wisconsin Ginseng for Decreasing Cancer Related Fatigue
ClinicalTrials.gov ID: NCT06395441
What this study is testing
- What it's testing
- This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue.
- Phase 3: a large, late-stage study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale.
- Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
You likely can't join if
- Any known hypersensitivity to ginseng
- Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants.
- Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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
- 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
What rules you out
- Any known hypersensitivity to ginseng
- Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants.
- 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)...
- Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)
- 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 treatment clinical trial
The study team makes the final eligibility decision.
Where it is enrolling
- Albert Lea, Minnesota, United States
- Bemidji, Minnesota, United States
- Brainerd, Minnesota, United States
- Deer River, Minnesota, United States
- Detroit Lakes, Minnesota, United States
- Duluth, Minnesota, United States
- Fosston, Minnesota, United States
- Hibbing, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- Sandstone, Minnesota, United States
- Thief River Falls, Minnesota, United States
- Virginia, Minnesota, United States
- Worthington, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Albert Lea, Minnesota, United States; Bemidji, Minnesota, United States; Brainerd, Minnesota, United States; Deer River, Minnesota, United States; Detroit Lakes, Minnesota, United States; Duluth, Minnesota, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.