Status:
COMPLETED
American Ginseng in Treating Patients With Cancer-Related Fatigue
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00182780
Start Date
October 1 2005
End Date
April 1 2010
Last Update
October 31 2017
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