|No phase specified||Supportive care||Completed||18 and over||NCI, Other||CDR0000440907|
NCCTG-N03CA, N03CA, NCT00182780
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.
Further Study Information
- 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 (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.
- 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, 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.
- 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
- No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diabetes, defined as receiving oral hypoglycemics or insulin
- No hypersensitivity to ginseng
- No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue
- Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
PRIOR CONCURRENT THERAPY:
- Concurrent epoetin alfa for treatment of anemia allowed
- Concurrent chemotherapy allowed except CHOP therapy
- No concurrent chronic systemic steroids
- Not specified
- More than 4 weeks since prior major surgery
- No prior ginseng capsules for fatigue
- Prior ginseng-containing teas or drinks purchased at a grocery store allowed
- No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:
- Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
- No concurrent monoamine oxidase inhibitors
- No concurrent full anticoagulation doses of warfarin or heparin
- A dose of 1 mg/day for preventing catheter clots allowed
Trial Lead Organizations/Sponsors
North Central Cancer Treatment GroupNational Cancer Institute
|Brent A. Bauer||Study Chair|
|Charles L. Loprinzi|
|Teresa A. Rummans|
|Tait D. Shanafelt|
|Patricia A. Johnson|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00182780
Information obtained from ClinicalTrials.gov on February 27, 2013
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