American Ginseng in Treating Patients With Cancer-Related Fatigue - Article
Clinical Trial: American Ginseng in Treating Patients With Cancer-Related Fatigue
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005
RATIONALE: American ginseng may help relieve cancer-related fatigue.
unspecified adult solid tumor, protocol specific
| Drug: ginseng |
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: fatigue assessment/management
Procedure: herbal medicine / botanical therapy
Procedure: supportive care/therapy
MedlinePlus related topics: Cancer; Cancer Alternative Therapies
Study Type: Interventional
Study Design: Treatment
Official Title: Randomized Study of American Ginseng in Patients With Cancer-Related Fatigue
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.
- Determine the toxic effects and tolerability of American ginseng in these patients.
- Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
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, baseline fatigue score (5-7 vs 8-10), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral American ginseng as in arm I, but at a higher dose.
- Arm III: Patients receive oral American ginseng as in arm I, but at a higher dose than arm II.
- Arm IV: 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.
Quality of life is assessed at baseline and then at the end of weeks 4 and 8 of both the double-blind and optional continuation portion of the study.
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months.
- Histologically or cytologically confirmed cancer
- Experiences cancer-related fatigue, defined as a baseline fatigue score of > 4 on a numerical analogue scale (0-10)
- Fatigue must be present for ≥ 1 month before study entry
- No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma
- 18 and over
- ECOG 0-2
- At least 6 months
- Hemoglobin ≥ 11 g/dL
- SGOT ≤ 1.5 times upper limit of normal (ULN)
- Calcium ≤ 1.2 times ULN
- Creatinine ≤ 1.2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diabetes
- No hypersensitivity to ginseng
- No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient''''s fatigue
- No psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
PRIOR CONCURRENT THERAPY:
- Concurrent chemotherapy allowed
- Not specified
- More than 4 weeks since prior major surgery
- More than 2 weeks since prior pharmacologic agents for the treatment of fatigue, including any of the following:
- Antidepressants used to treat conditions other than fatigue are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
- No prior ginseng capsules for fatigue
- Prior or concurrent ginseng-containing teas or drinks purchased at a grocery store allowed
- No concurrent monoamine oxidase inhibitors
- No concurrent warfarin except if used at a dose of 1 mg/day for preventing catheter clots
- No other concurrent pharmacologic agents for fatigue
Location and Contact Information
Brent A. Bauer, MD, Study Chair, Mayo Clinic Cancer Center
Charles L. Loprinzi, MD, Mayo Clinic Cancer Center
Teresa A. Rummans, MD, Mayo Clinic Cancer Center
Tait D. Shanafelt, MD, Mayo Clinic Cancer Center
Last Updated: September 15, 2005
Record first received: September 15, 2005
ClinicalTrials.gov Identifier: NCT00182780
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20
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