american ginseng in treating patients with cancer-related fatigue

Conditions: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Summary: 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 * compare the efficacy of american ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue. secondary * 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.

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

Keywords: fatigue unspecified adult solid tumor, protocol specific