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| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066859 |
Purpose
RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's wort) may be effective in treating mild to moderate depression. It is not yet known which treatment is more effective in improving depression in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well sertraline works compared to St. John's wort in treating mild to moderate depression in patients with solid tumors.
| Condition | Intervention | Phase |
|
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: St. John's wort Drug: sertraline hydrochloride |
Phase III |
| MedlinePlus related topics: | Cancer Depression |
| Drug Information available for: | Sertraline hydrochloride Sertraline |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| Official Title: | A Phase III Double-Blind Randomized Trial Comparing Sertraline (Zoloft) And Hypericum Perforatum (St. John's Wort) In Cancer Patients With Mild To Moderate Depression |
| Study Start Date: | August 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to level of depression (mild vs moderate), concurrent radiotherapy (yes vs no), and TNM stage (I, II, or III vs IV). Patients are randomized to 1 of 2 treatment arms.
Measurements of depression, somnolence, nausea, insomnia, fatigue, and hyperforin concentration are assessed at baseline, and at 1, 2, and 4 months.
PROJECTED ACCRUAL: A maximum of 250 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
Diagnosis of mild to moderate depression
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following:
Contacts and Locations| United States, California | |||||
| Bay Area Tumor Institute | |||||
| Oakland, California, United States, 94609-3305 | |||||
| United States, Georgia | |||||
| Regional Radiation Oncology Center at Rome | |||||
| Rome, Georgia, United States, 30165 | |||||
| United States, Illinois | |||||
| CCOP - Central Illinois | |||||
| Decatur, Illinois, United States, 62526 | |||||
| United States, North Carolina | |||||
| High Point Regional Hospital | |||||
| High Point, North Carolina, United States, 27261 | |||||
| Comprehensive Cancer Center at Wake Forest University | |||||
| Winston-Salem, North Carolina, United States, 27157-1082 | |||||
| CCOP - Southeast Cancer Control Consortium | |||||
| Goldsboro, North Carolina, United States, 27534-9479 | |||||
| Wake Forest University |
| National Cancer Institute (NCI) |
| Study Chair: | Antonius A. Miller, MD | Wake Forest University |
| Investigator: | Stephen Rapp, PhD | Wake Forest University |
| Investigator: | Edward G. Shaw, MD | Wake Forest University |
| Investigator: | W. Vaughn McCall, MD | Wake Forest University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000320508, CCCWFU-98101, CCCWFU-BGOI-152 |
| First Received: | August 6, 2003 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066859 |
| Health Authority: | United States: Federal Government |
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