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RecruitingInterventionalPhase 3

Phase III Study of Ginseng for Cancer Related Fatigue

NCT ID: NCT06395441Sponsor: Mayo ClinicLast updated: 2026-03-30

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.

Detailed description

PRIMARY OBJECTIVE: 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.

Arms & interventions

  • Dietary SupplementAmerican Ginseng

    Given PO

  • DrugPlacebo Administration

    Given PO

  • OtherQuestionnaire Administration

    Ancillary studies

Outcome measures

Primary

  • Change in fatigue

    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.

    Time frame: Baseline to 8 weeks

Secondary

  • Change in fatigue

    Time frame: Baseline, 4 and 8 weeks

  • Percentage of patients who perceive moderate to very much better fatigue

    Time frame: At 8 weeks

  • Incidence of adverse events

    Time frame: Up to 8 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Age ≥ 18 years * 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: * 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 * Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)

Study locations (15)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007

Recruiting
Clinical Trials Referral Office · Contact
Danielle Mutschler · Contact
Mina Hanna, MD · Principal Investigator

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

Recruiting
Jarrett Failing, MD · Contact
Jarrett Failing, MD · Principal Investigator

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Essentia Health Deer River Clinic

Deer River, Minnesota, 56636

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Essentia Health St. Mary's Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Essentia Health Cancer Center

Duluth, Minnesota, 55805

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Essentia Health Fosston

Fosston, Minnesota, 56542

Recruiting
Bret Friday, MD · Contact
Bret 1 Friday, MD · Principal Investigator

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Mayo Clinic Health System-Mankato

Mankato, Minnesota, 56001

Recruiting
Clinical Trials Referral Office · Contact
Jenna Ziegler · Contact
Stephan Thome, MD · Principal Investigator

MMCORC CentraCare Monticello Cancer Center

Monticello, Minnesota, 55362

Completed

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Daniel S. Childs, M.D. · Principal Investigator
Stacy D. D'Andre, M.D. · Principal Investigator

Essentia Health Sandstone

Sandstone, Minnesota, 55072

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701

Recruiting
Amit Panwalkar, MD · Contact
Amit Panwalkar, MD · Principal Investigator

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

Recruiting
Bret Friday, MD · Contact
Bret Friday, MD · Principal Investigator

Sanford Worthington Medical Center

Worthington, Minnesota, 56187

Recruiting
Jonathan Bleeker, MD · Contact
Jonathan Bleeker, MD · Principal Investigator