Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer - Article Botanicals; Herbalism; Medicinal Herbs
Clinical Trial: Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
unspecified adult solid tumor, protocol specific
| Drug: Hypericum perforatum |
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: herbal medicine / botanical therapy
Procedure: nutritional supplementation
Procedure: psychosocial assessment/care
Procedure: supportive care/therapy
|Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Depression
Study Type: Interventional
Study Design: Treatment
- 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically or cytologically confirmed solid tumor
- No hematologic malignancy (e.g., leukemia, lymphoma, or multiple myeloma)
- Diagnosis of mild to moderate depression
- No severe depression or suicidal ideation
- No psychotic symptoms, dementia, or marked agitation requiring medication
- No brain metastases or primary brain tumor
PATIENT CHARACTERISTICS: Age
- 18 and over
- ECOG 0-1
- More than 4 months
- Hemoglobin greater than 10 g/dL
- Bilirubin no greater than 1.5 mg/dL
- Not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior or concurrent alcohol abuse or drug dependence
PRIOR CONCURRENT THERAPY: Biologic therapy
- No concurrent epoetin alfa (e.g., Procrit® or Aranesp®)
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
- No concurrent chemotherapy
- No concurrent corticosteroids
- Prior or concurrent radiotherapy allowed except brain irradiation for brain metastases or primary brain tumor
- Not specified
- More than 4 weeks since prior antidepressants or Hypericum perforatum
- No concurrent warfarin (central line prophylaxis allowed)
- No concurrent administration of any of the following:
- Protease inhibitors used to treat AIDS
- Benzodiazepines (e.g., diazepam or alprazolam)
- Calcium-channel blockers (e.g., diltiazem or nifedipine)
- Coenzyme A reductase inhibitors (cholesterol-lowering agents)
- Macrolide antibiotics (e.g., azithromycin, erythromycin, or clarithromycin)
- Grapefruit juice
- Naturopathic/herbal products that would interfere with Hypericum perforatum
Location and Contact Information
Regional Radiation Oncology Center at Rome, Rome, Georgia, 30165, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
Alamance Cancer Center, Burlington, North Carolina, 27216, United States; Recruiting
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
High Point Regional Hospital, High Point, North Carolina, 27261, United States; Recruiting
Antonius A. Miller, MD, Study Chair, Comprehensive Cancer Center of Wake Forest University
Stephen Rapp, PhD, Comprehensive Cancer Center of Wake Forest University
Edward G. Shaw, MD, Comprehensive Cancer Center of Wake Forest University
W. Vaughn McCall, MD, Comprehensive Cancer Center of Wake Forest University
Record last reviewed: July 2004
Last Updated: April 4, 2005
Record first received: August 6, 2003
ClinicalTrials.gov Identifier: NCT00066859
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005