American Ginseng in Treating Patients With Fatigue Caused by Cancer (NCT00719563) | Clinical Trial Compass
CompletedPhase 3
American Ginseng in Treating Patients With Fatigue Caused by Cancer
United States364 participantsStarted 2008-10
Plain-language summary
RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.
PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Required characteristics
* ≥ 18 years of age
* Men or women with a history of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)
* The presence of fatigue ≥ 1 month prior to randomization
* ECOG performance score 0, 1, or 2
* Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma, undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or those having completed curative intent therapy who were diagnosed within the past 2 years
* Note: If a patient is receiving treatment for their disease such as chemotherapy, targeted therapies, immunotherapy or radiation therapy then, the patient must have completed ≥ 1 cycle of chemotherapy, targeted therapy, or ≥ 1 week of radiation treatment.
* Laboratory values obtained prior to randomization:
* Hgb ≥ 11 (must be obtained ≤ 30 days; patients must not be transfused ≤ 30 days to meet this criterion)
* Creatinine ≤ 1.2 x UNL (must be obtained ≤ 180 days prior to randomization)
* AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (must be obtained ≤ 180 days prior to randomization)
* Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
* Ability to complete patient questionnaires alone or with assistance
* Controlled:
* Pain (≤ 4 on Linear Analogue Scale)
* Insomnia (≤ 4 on Linear Analogue Scale)
* Willing…
What they're measuring
1
Change From Baseline to Week 4 in the General Subscale of the MFSI-SF