Malignant Solid Neoplasm
Conditions
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.
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_SUPPLEMENTAmerican Ginseng
Given PO
DRUGPlacebo Administration
Given PO
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | Baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | Baseline, 4 and 8 weeks | Will be measured by the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) Scale, which consists of 13 questions answered on a scale of 0-4 where 0=not at all and 4=very much. |
| Percentage of patients who perceive moderate to very much better fatigue | At 8 weeks | Will be measured by the Global Impression of Change, which consists of 3 questions answered on a scale of -3 (very much worse) to 3 (very much better), one question as to whether the participants thought they were receiving the intervention (ginseng) or placebo, and one question related to satisfaction with the effect of the treatment on their fatigue (yes/no). |
| Incidence of adverse events | Up to 8 weeks | Will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) and/or the Ginseng Symptom Experience Diary and compared between arms. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORDaniel S. Childs, MD
Mayo Clinic in Rochester
Outcome results
None listed