Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Trial Title: Wisconsin Ginseng for Decreasing Cancer Related Fatigue

NCT ID: NCT06395441

Condition: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Investigator)

Masking description: 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.

Intervention:

Intervention type: Dietary Supplement
Intervention name: American Ginseng
Description: Given PO
Arm group label: Group I (Western ginseng)

Other name: Ginseng

Other name: Ginseng Root

Other name: Panax quinquifolius

Intervention type: Drug
Intervention name: Placebo Administration
Description: Given PO
Arm group label: Group II (placebo)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Group I (Western ginseng)
Arm group label: Group II (placebo)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥ 18 years - 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Daniel S. Childs, M.D.
Email: Principal Investigator

Investigator:
Last name: Stacy D. D'Andre, M.D.
Email: Principal Investigator

Investigator:
Last name: Charles L. Loprinzi, M.D.
Email: Principal Investigator

Start date: August 1, 2024

Completion date: November 2026

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06395441
https://www.mayo.edu/research/clinical-trials