Back to resultsAmerican Ginseng in Treating Patients With Cancer-Related Fatigue
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring fatigue, unspecified adult solid tumor, protocol specific
Eligibility Criteria
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) Fatigue must be present for ≥ 1 month before study entry No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic Hemoglobin ≥ 11 g/dL Hepatic SGOT ≤ 1.5 times upper limit of normal (ULN) Renal Calcium ≤ 1.2 times ULN Creatinine ≤ 1.2 times ULN Cardiovascular No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160) Other 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: Biologic therapy Concurrent epoetin alfa for treatment of anemia allowed Chemotherapy Concurrent chemotherapy allowed except CHOP therapy Endocrine therapy No concurrent chronic systemic steroids Radiotherapy Not specified Surgery More than 4 weeks since prior major surgery Other 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: Psychostimulants Antidepressants 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Other
Arm I - American ginseng (low dose)
Arm II - American ginseng (mid-dose)
Arm III - American ginseng (high-dose)
Arm IV - Placebo
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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