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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02670 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000440907 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: American ginseng may help relieve cancer-related fatigue.
PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I - American ginseng (low dose) | Experimental | Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment. PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months. |
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| Arm II - American ginseng (mid-dose) | Experimental | Patients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
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| Arm III - American ginseng (high-dose) | Experimental | Patients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| American ginseng | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue by brief inventory at 4 and 8 weeks of treatment | at 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment | at 4 and 8 weeks | |
| Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment | at 4 and 8 weeks |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cancer
Experiences cancer-related fatigue, defined as a baseline fatigue score of ≥ 4 on a numerical analogue scale (0-10)
No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No prior ginseng capsules for fatigue
No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:
Psychostimulants
Antidepressants
No concurrent monoamine oxidase inhibitors
No concurrent full anticoagulation doses of warfarin or heparin
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| Name | Affiliation | Role |
|---|---|---|
| Brent A. Bauer, MD | Mayo Clinic | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19415341 | Result | Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Arm IV - Placebo | Other | Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
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| Placebo | Other |
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