Does Hypericum Reduce Fatigue in Cancer Patients on Chemotherapy? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
OBJECTIVES: I. Determine the efficacy of Hypericum perforatum (St. John's Wort) in relieving
fatigue in patients undergoing chemotherapy or hormonal therapy for malignant disease. II.
Determine the relationship between fatigue, depression, and anxiety in these patients. III.
Determine the correlation between quality of sleep and level of fatigue in these patients.
OUTLINE: This is a randomized, placebo controlled study. Patients are randomized to one of
two treatment arms. Arm I: Patients receive oral Hypericum perforatum (St. John's Wort) 3
times a day. Arm II: Patients receive an oral placebo 3 times a day. Treatment continues for
6 weeks in the absence of worsening symptoms or unacceptable toxicity. Patients complete the
Profile of Mood States (POMS) and the Brief Fatigue Inventory at the beginning and end of
PROJECTED ACCRUAL: A total of 220 patients (110 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Supportive Care
David J. Straus, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|