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.
OBJECTIVES: * Compare the change in depression severity in cancer patients with mild to moderate depression treated with sertraline vs Hypericum perforatum. * Compare the severity of somnolence, nausea, and insomnia in patients treated with these regimens. * Compare the impact of these regimens on fatigue in these patients. * Correlate hyperforin concentrations with change in depression severity in patients treated with Hypericum perforatum. 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. * Arm I: Patients receive oral sertraline daily. * Arm II: Patients receive oral Hypericum perforatum daily. In both arms, treatment continues for 4 months in the absence of unacceptable toxicity. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
2
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
Bay Area Tumor Institute
Oakland, California, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Depression severity as measured by Hamilton Depression rating scale.
To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.
Time frame: 4 months
Somnolence, nausea, and insomnia as assessed by the NCI Common Toxicity Criteria. The Epworth Sleepiness Scale will also be used to assess somnolence.
Time frame: 4 months
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.
Time frame: 4 months
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High Point Regional Hospital
High Point, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States