Wisconsin Ginseng for Decreasing Cancer Related Fatigue
NCT ID: NCT06395441
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2024-08-01
2026-11-30
Brief Summary
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Detailed Description
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I. To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks.
SECONDARY OBJECTIVES:
I. 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group I (Western ginseng)
Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
American Ginseng
Given PO
Questionnaire Administration
Ancillary studies
Group II (placebo)
Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Interventions
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American Ginseng
Given PO
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has received or is receiving treatment for a solid-organ malignancy (not hematologic)
* 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
* Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration)
* Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration)
* Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration)
* No clinical suspicion of hypothyroidism within 180 days prior to registration \[if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) \< 5 milli-international units per liter (mIU/L) is required\]
* 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
* 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
* Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Daniel S. Childs, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health Deer River Clinic
Deer River, Minnesota, United States
Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Fosston
Fosston, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota, United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Sanford Worthington Medical Center
Worthington, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Danielle Mutschler
Role: backup
Jarrett Failing, MD
Role: primary
Bret Friday, MD
Role: primary
Bret Friday, MD
Role: primary
Bret Friday, MD
Role: primary
Bret Friday, MD
Role: primary
Bret Friday, MD
Role: primary
Bret Friday, MD
Role: primary
Clinical Trials Referral Office
Role: primary
Jenna Ziegler
Role: backup
Clinical Trials Referral Office
Role: primary
Bret Friday, MD
Role: primary
Amit Panwalkar, MD
Role: primary
Bret Friday, MD
Role: primary
Jonathan Bleeker, MD
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-03375
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-012122
Identifier Type: OTHER
Identifier Source: secondary_id
MC231004
Identifier Type: OTHER
Identifier Source: secondary_id
MNCCTN037
Identifier Type: OTHER
Identifier Source: secondary_id
MC231004
Identifier Type: -
Identifier Source: org_study_id