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.

Sponsors and Collaborators: Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Randomized phase III trial to compare the effectiveness of sertraline with that of St. John's wort in treating mild to moderate depression in patients who have solid tumors.

Condition Treatment or Intervention Phase
Depression
unspecified adult solid tumor, protocol specific
 Drug: Hypericum perforatum
 Drug: sertraline
 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

Official Title: Phase III Randomized Study of Sertraline (Zoloft®) Versus Hypericum Perforatum (St. John's Wort) in Cancer Patients With Mild to Moderate Depression

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

Performance status

  • ECOG 0-1

Life expectancy

  • More than 4 months

Hematopoietic

  • Hemoglobin greater than 10 g/dL

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Not specified

Other

  • 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

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroids

Radiotherapy

Surgery

  • Not specified

Other

  • 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:
  • Theophylline
  • Protease inhibitors used to treat AIDS
  • Digoxin
  • Cyclosporine
  • 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)
  • Griseofulvin
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Rifabutin
  • Ketoconazole
  • Fluconazole
  • Itraconazole
  • Grapefruit juice
  • Naturopathic/herbal products that would interfere with Hypericum perforatum

Location and Contact Information


Georgia
      Regional Radiation Oncology Center at Rome, Rome,  Georgia,  30165,  United States; Recruiting
Matt P. Mumber, MD  706-234-1400    mmumber@rrocrome.com 

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

North Carolina
      Alamance Cancer Center, Burlington,  North Carolina,  27216,  United States; Recruiting
Geoffrey Browne, MD  336-538-7445 

      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
Antonius A. Miller, MD  336-713-4392 

      High Point Regional Hospital, High Point,  North Carolina,  27261,  United States; Recruiting
Bernard Chinnasami, MD  336-878-6924 

Study chairs or principal investigators

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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000320508; CCCWFU-98101; CCCWFU-BGOI-152; NCT00066859
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005