American Ginseng in Treating Patients With Cancer-Related Fatigue

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