Malignant Solid NeoplasmPhase 3NCT06395441
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
A Phase 3 study testing American Ginseng and Questionnaire Administration in people with Malignant Solid Neoplasm and Chronic Lymphocytic Leukemia, run by Mayo Clinic at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm, Chronic Lymphocytic Leukemia, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- American Ginseng and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Aug 2024to 30 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 14 recruiting
- Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Danielle Mutschler, 507-377-4817, Mutschler.Danielle@mayo.edu
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Jarrett Failing, MD, 612-624-2620, ccinfo@umn.edu
Jarrett Failing, MD
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Essentia Health Deer River Clinic
Deer River, Minnesota, 56636
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Bret Friday, MD, 218-786-3625, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Essentia Health Fosston
Fosston, Minnesota, 56542
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret 1 Friday, MD
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jenna Ziegler, 507-594-7479, Ziegler.Jenna@mayo.edu
- Completed
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Daniel S. Childs, M.D.
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Amit Panwalkar, MD, 612-624-2620, ccinfo@umn.edu
Amit Panwalkar, MD
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Bret Friday, MD, 612-624-2620, ccinfo@umn.edu
Bret Friday, MD
- Recruiting
Sanford Worthington Medical Center
Worthington, Minnesota, 56187
Jonathan Bleeker, MD, jonathan.bleeker@sanfordhealth.org
Jonathan Bleeker, MD
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks.
SECONDARY OBJECTIVES:
- To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4, the Global Impression of Change at week 4 and 8, and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at week 4 and 8.
II. To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate (on a 0 to 10 scale) their toxicities experienced while on study.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive Western ginseng orally (PO) twice daily (BID) on days 1-56.
GROUP II: Patients receive placebo PO BID on days 1-56.
- Conditions
- Malignant Solid Neoplasm, Chronic Lymphocytic Leukemia, Hematopoietic and Lymphatic System Neoplasm, Hodgkin Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma
- Being tested
- American Ginseng, Placebo Administration, Questionnaire Administration
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease, Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American GinsengDietary supplement
Also called Ginseng, Ginseng Root, Panax quinquifolius
Given PO
Placebo AdministrationDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Western ginseng) | Experimental | Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: American Ginseng; Other: Questionnaire Administration |
| Group II (placebo) | Placebo comparator | Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue at 8 weeks
Will be measured by the Linear Analog Scale for Fatigue, a single-item questionnaire rating fatigue over the pats week on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be.
Measured: Baseline to 8 weeks
Secondary outcomes (3)
Percentage of patients who perceive moderate to very much better fatigue
Will be measured by the Global Impression of Change scale, which consists of 3 questions answered on a scale of -3 (very much worse) to 3 (very much better), one question as to whether the participants thought they were receiving the intervention (ginseng) or placebo, and one question related to satisfaction with the effect of the treatment on their fatigue (yes/no).
Measured: 4 weeks, 8 weeks
Change in Fatigue - FACIT-Fatigue
Will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale, which consists of 13 questions answered on a scale of 0-4 where 0=not at all and 4=very much.
Measured: 4 weeks, 8 weeks
Patient-reported Toxicities - Ginseng Symptom Experience Diary
Will be measured using the Ginseng Symptom Experience Diary, where patients rate toxicities experienced while on study. The diary asks patients to rate a list of 7 symptoms over the past week on a scale of 0 (none at all) to 10 (as bad as it can be), with higher scores indicating greater severity of symptoms.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel S. Childs, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395441
- Sponsor's protocol ID
- MC231004
- Other IDs
- 23-012122, MNCCTN037
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No