American Ginseng in Treating Patients With Cancer-Related Fatigue

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study

Conditions
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Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Dietary Supplement: American ginseng
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I - American ginseng (low dose)<br>Patients receive oral American ginseng 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. | Dietary Supplement: American ginseng<br> <br> |
| Experimental: Arm II - American ginseng (mid-dose)<br>Patients receive oral American ginseng at the mid-dose 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. | Dietary Supplement: American ginseng<br> <br> |
| Experimental: Arm III - American ginseng (high-dose)<br>Patients receive oral American ginseng at the high dose 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. | Dietary Supplement: American ginseng<br> <br> |
| Other: Arm IV - Placebo<br>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. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue by brief inventory at 4 and 8 weeks of treatment |  | at 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, unspecified adult solid tumor, protocol specific