|
|
 |
|
 |
|
|
|
|
Title:
|
The Use of Wisconsin Ginseng (panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study - IRB# 09-01A
|
|
Treatments:
|
Wisconsin Ginseng
|
|
Disease Site:
|
Cancer control
|
|
Disease SubSite:
|
Fatigue
|
|
Drug Provided:
|
Wisconsin Ginseng
|
|
Comments:
|
|
|
Eligibility:
|
Diagnosis of histologically or cytologically proven cancer within the past 2 years. Currently undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or completed curative intent therapy. Must have completed >1 course of chemotherapy or targeted therapy or > 1 week of radiation therapy. Not planning to start new or complete cancer therapy during study. History of cancer-related fatigue as defined by an average score of => 4 over the past 30 days on the numeric analogue scale (0–10). Experiencing fatigue for > 1 month. No known brain metastasis or primary CNS malignancy. Prior/Concurrent Therapy: See Disease Characteristics. More than 4 weeks since prior major surgery including any procedure that requires general anesthetic. Concurrent erythropoietin agents for anemia allowed. No prior use of ginseng capsules for fatigue. Prior teas or beverages containing ginseng are allowed. No concurrent over-the-counter herbal/dietary supplement marketed for fatigue or energy (e.g., products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an “adaptogen”). No concurrent pharmacologic agent that specifically treats fatigue including, but not limited to, psychostimulants or antidepressants except antidepressants to treat conditions other than fatigue (e.g., hot flashes) provided patient has been on a stable dose for =>1 month and plans to continue for =>1 month. No concurrent chronic systemic steroids (including as part of cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone [CHOP] therapy or any regular cancer treatment) except as prophylaxis for nausea and vomiting. No concurrent full dose anticoagulant therapy. 1 mg/day of coumadin for preventing catheter clots allowed. No concurrent monoamine oxidase inhibitors. No concurrent single agent on a blinded placebo controlled treatment trial.
|
|
Participating Sites:
|
Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
|
|
|
|
|
 |
|
 |
|
|
|