The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
18 Years
N/A
Both
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Fatigue by brief inventory at 4 and 8 weeks of treatment
Principal Investigator
Brent A. Bauer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000440907
NCT ID:
NCT00182780
Start Date:
October 2005
Completion Date:
Related Keywords:
- Fatigue
- Unspecified Adult Solid Tumor, Protocol Specific
- fatigue
- unspecified adult solid tumor, protocol specific
- Fatigue
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