Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005805
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2000-06-02
Brief Title:
St Johns Wort in Relieving Fatigue in Patients Undergoing Chemotherapy or Hormone Therapy for Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Does Hypericum Reduce Fatigue in Cancer Patients on Chemotherapy A Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving St Johns 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 Johns wort in relieving fatigue in patients who are undergoing chemotherapy or hormone therapy for cancer
PURPOSE Randomized phase III trial to determine the effectiveness of St Johns 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 Johns 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 Johns 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
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 Johns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1772 | None | None | None |
| MSKCC-99102 | None | None | None |