Using Wisconsin ginseng to reduce cancer-related fatigue

Phase III Study of Ginseng for Cancer Related Fatigue

This study is testing if Wisconsin ginseng can help reduce fatigue in cancer patients compared to a placebo over eight weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 15 sites (Albert Lea, Minnesota and 14 other locations)
• Trial ID: NCT06395441 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of Wisconsin ginseng (panax quinquefolius) compared to a placebo in alleviating significant fatigue in cancer patients. The primary objective is to measure changes in fatigue levels over an 8-week period using a single-item fatigue measure. Secondary objectives include assessing changes in fatigue at 4 weeks, evaluating patient-reported toxicity, and using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale. Patients will be randomly assigned to receive either ginseng or a placebo for 56 days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of cancer-related fatigue and controlled insomnia and pain.

Not a fit: Patients with severe fatigue not meeting the study's inclusion criteria or those with uncontrolled symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for managing cancer-related fatigue.

How similar studies have performed: Other studies have shown promise in using ginseng for fatigue management, suggesting potential success for this approach.

Eligibility criteria

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)

Where this trial is running

Albert Lea, Minnesota and 14 other locations

• Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Recruiting)
• Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States (Recruiting)
• Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States (Recruiting)
• Essentia Health Deer River Clinic — Deer River, Minnesota, United States (Recruiting)
• Essentia Health St. Mary's Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States (Recruiting)
• Essentia Health Cancer Center — Duluth, Minnesota, United States (Recruiting)
• Essentia Health Fosston — Fosston, Minnesota, United States (Recruiting)
• Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States (Recruiting)
• Mayo Clinic Health System-Mankato — Mankato, Minnesota, United States (Recruiting)
• MMCORC CentraCare Monticello Cancer Center — Monticello, Minnesota, United States (Completed)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
• Essentia Health Sandstone — Sandstone, Minnesota, United States (Recruiting)
• Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota, United States (Recruiting)
• Essentia Health Virginia Clinic — Virginia, Minnesota, United States (Recruiting)
• Sanford Worthington Medical Center — Worthington, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Daniel S. Childs, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office

Conditions Malignant Solid Neoplasm