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American Ginseng in Treating Patients With Cancer-Related Fatigue

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182780
Enrollment
290
Registered
2005-09-16
Start date
2005-10-31
Completion date
2010-04-30
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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

DIETARY_SUPPLEMENTAmerican ginseng
OTHERPlacebo

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Fatigue by brief inventory at 4 and 8 weeks of treatmentat 4 and 8 weeks

Secondary

MeasureTime frame
Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatmentat 4 and 8 weeks
Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatmentat 4 and 8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026