Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

• Arm I: Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.

• Arm II: Patients receive oral American ginseng as in arm I, but at a higher dose.

• Arm III: Patients receive oral American ginseng as in arm I, but at a higher dose than arm II.

• Arm IV: 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.

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

Brent A. Bauer

Study Chair

Charles L. Loprinzi

Teresa A. Rummans

Tait D. Shanafelt

Patricia A. Johnson

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00182780
Information obtained from ClinicalTrials.gov on February 27, 2013

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