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| ID | Type | Description | Link |
|---|---|---|---|
| 23-012122 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MNCCTN037 | Other Identifier | MN Cancer Clinical Trials Network |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Western ginseng) | Experimental | Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity. |
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| Group II (placebo) | Placebo Comparator | Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| American Ginseng | Dietary Supplement | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel S. Childs, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System in Albert Lea | Recruiting | Albert Lea | Minnesota | 56007 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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.
| Placebo Administration | Drug | Given PO |
|
| Questionnaire Administration | Other | Ancillary studies |
|
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 | 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 |
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| Essentia Health Cancer Center | Recruiting | Duluth | Minnesota | 55805 | United States |
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| Mayo Clinic Health System-Mankato | Recruiting | Mankato | Minnesota | 56001 | United States |
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| MMCORC CentraCare Monticello Cancer Center | Completed | Monticello | Minnesota | 55362 | United States |
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| Sanford Worthington Medical Center | Recruiting | Worthington | Minnesota | 56187 | United States |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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