Lymphoma Clinical Trial
Official title:
Does Hypericum Reduce Fatigue in Cancer Patients on Chemotherapy? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
RATIONALE: Giving St. John's wort may be effective in relieving fatigue in patients with
cancer who are undergoing chemotherapy or hormone therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of St. John's wort in
relieving fatigue in patients who are undergoing chemotherapy or hormone therapy for cancer.
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
the study.
PROJECTED ACCRUAL: A total of 220 patients (110 per arm) will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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