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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00005805
Study type Interventional
Source Memorial Sloan Kettering Cancer Center
Contact
Status Completed
Phase Phase 3
Start date December 1999

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