American Ginseng 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.

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