Wisconsin Ginseng for Decreasing Cancer Related Fatigue

NCT06395441 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: MC23100423-012122MNCCTN037
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 8 weeks

Secondary Outcomes (3)

• Change in fatigue

  Baseline, 4 and 8 weeks

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

  At 8 weeks

• Incidence of adverse events

  Up to 8 weeks

Study Arms (2)

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.

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.

Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

American Ginseng DIETARY_SUPPLEMENT

Given PO

Also known as: Ginseng, Ginseng Root, Panax quinquifolius

Group I (Western ginseng)

Placebo Administration DRUG

Given PO

Group II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Group I (Western ginseng); Group II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (15)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Essentia Health Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health St. Mary's Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

RECRUITING

Essentia Health Fosston

Fosston, Minnesota, 56542, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Mayo Clinic Health System-Mankato

Mankato, Minnesota, 56001, United States

RECRUITING

MMCORC CentraCare Monticello Cancer Center

Monticello, Minnesota, 55362, United States

COMPLETED

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

RECRUITING

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

Sanford Worthington Medical Center

Worthington, Minnesota, 56187, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Asian ginseng

Study Officials

• Daniel S. Childs, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Research staff, other than pharmacy, are blinded, and will dispense product to the patient. Option to unblind: At the end of treatment, if, in the judgment of patient or patient's attending clinician, it would be helpful for the future of patient's clinical care, the code may be broken.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (15)