Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
fatigue, unspecified adult solid tumor, protocol specific
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue by brief inventory at 4 and 8 weeks of treatment | at 4 and 8 weeks |
Secondary
| Measure | 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 |