- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06395441
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Phase III Study of Ginseng for Cancer Related Fatigue
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
Principal Investigator:
- Stacy D. D'Andre, M.D.
-
Principal Investigator:
- Charles L. Loprinzi, M.D.
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Daniel S. Childs, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (Western ginseng)
Patients receive Western ginseng PO BID on days 1-56.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Given PO
Other Names:
|
Placebo Comparator: Group II (placebo)
Patients receive placebo PO BID on days 1-56.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Given PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fatigue
Time Frame: 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.
|
Baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fatigue
Time Frame: 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.
|
Baseline, 4 and 8 weeks
|
Percentage of patients who perceive moderate to very much better fatigue
Time Frame: 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).
|
At 8 weeks
|
Incidence of adverse events
Time Frame: 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.
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel S. Childs, M.D., Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC231004 (Other Identifier: Mayo Clinic in Rochester)
- NCI-2024-03375 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 23-012122 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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