Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	CCCWFU-98101 CCCWFU-BGOI-152, NCT00066859

Objectives

1. Compare the change in depression severity in cancer patients with mild to moderate depression treated with sertraline vs Hypericum perforatum.
2. Compare the severity of somnolence, nausea, and insomnia in patients treated with these regimens.
3. Compare the impact of these regimens on fatigue in these patients.
4. Correlate hyperforin concentrations with change in depression severity in patients treated with Hypericum perforatum.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent epoetin alfa (e.g., Procrit® or Aranesp®)

Chemotherapy

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

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• Prior or concurrent radiotherapy allowed except brain irradiation for brain metastases or primary brain tumor

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

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

Expected Enrollment

A maximum of 250 patients will be accrued for this study.

Outcomes

Compare the change in depression severity as measured by Hamilton Depression rating scale at 4 months

Compare the severity of somnolence, nausea, and insomnia at 4 months
Compare the impact of therapy at 4 months
Correlate the hyperforin concentrations with the change in depression severity at 4 months

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Antonius Miller, MD, Protocol chair		Ph: 336-713-4392; 800-446-2255
Stephen Rapp, PhD, Protocol co-chair		Ph: 336-716-6995 Email: srapp@wfubmc.edu
Edward Shaw, MD, Protocol co-chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu
W. Vaughn McCall, MD, Protocol co-chair		Ph: 336-716-2911 Email: vmccall@wfubmc.edu

Registry Information
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
Trial Start Date		2003-08-22
Registered in ClinicalTrials.gov		NCT00066859
Date Submitted to PDQ		2003-07-08
Information Last Verified		2005-09-06
NCI Grant/Contract Number		CA12197

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