St. John's Wort in Relieving Fatigue in Patients Undergoing Chemotherapy or Hormone Therapy for Cancer

Phase 3

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Leukemia; Fatigue; Myelodysplastic Syndromes; Chronic Myeloproliferative Disorders; Lymphoma; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00005805
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed 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 Timeline

• Study Start: 1999-12
• Primary Completion: 2000-06
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States