Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Official title

Phase III Study of Ginseng for Cancer Related Fatigue

Overview

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.

Interventions

• Dietary supplement American Ginseng
  Given PO
• Drug Placebo Administration
  Given PO
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Change in fatigue [Time frame: Baseline to 8 weeks]

Secondary outcome measures (3)

• 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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 15 centers

• Mayo Clinic Health System in Albert Lea — Albert Lea
• Sanford Joe Lueken Cancer Center — Bemidji
• Essentia Health Saint Joseph's Medical Center — Brainerd
• Essentia Health Deer River Clinic — Deer River
• Essentia Health St. Mary's Detroit Lakes Clinic — Detroit Lakes
• Essentia Health Cancer Center — Duluth
• Essentia Health Fosston — Fosston
• Essentia Health Hibbing Clinic — Hibbing
• … and 7 more centers

Identifiers

NCT: NCT06395441 · MC231004 · 23-012122 · MNCCTN037

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗