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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005805
Other study ID # 99-102
Secondary ID MSKCC-99102NCI-G
Status Completed
Phase Phase 3
First received June 2, 2000
Last updated January 17, 2013
Start date December 1999

Study information

Verified date January 2013
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Giving St. John's wort may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy or hormone therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of St. John's wort in relieving fatigue in patients who are undergoing chemotherapy or hormone therapy for cancer.


Description:

OBJECTIVES: I. Determine the efficacy of Hypericum perforatum (St. John's Wort) in relieving fatigue in patients undergoing chemotherapy or hormonal therapy for malignant disease. II. Determine the relationship between fatigue, depression, and anxiety in these patients. III. Determine the correlation between quality of sleep and level of fatigue in these patients.

OUTLINE: This is a randomized, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral Hypericum perforatum (St. John's Wort) 3 times a day. Arm II: Patients receive an oral placebo 3 times a day. Treatment continues for 6 weeks in the absence of worsening symptoms or unacceptable toxicity. Patients complete the Profile of Mood States (POMS) and the Brief Fatigue Inventory at the beginning and end of the study.

PROJECTED ACCRUAL: A total of 220 patients (110 per arm) will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date June 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: Patients with malignant disease receiving chemotherapy regimen for at least 6 weeks but less than 6 months, and continuing concurrent chemotherapy for at least 3-4 weeks OR Patients with malignant disease receiving hormonal therapy for at least 3 months prior to study, and continuing during entire study Profile of Mood States (POMS) Fatigue Subscale score of 14 or higher POMS Depression Subscale score of 13 or less

PATIENT CHARACTERISTICS: Age: Over 17 Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 10 g/dL No decline in hemoglobin of 2 g/dL or more for one month prior to study Hematocrit at least 30% Hepatic: SGOT no greater than 3 times upper limit of normal Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No unstable cardiac disease Pulmonary: No debilitating pulmonary disease Other: No uncontrolled pain No uncontrolled serious infection No significant comorbidity that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified Other: At least 1 month since prior Hypericum perforatum (St. John's Wort) No other concurrent St. John's Wort No concurrent monamine oxidase inhibitors (e.g., furazolidone, isocarboxazid, meclobremide, phenelzine, procarbazine, selegiline, and tranylcypromine) No concurrent sympathomimetic amines (e.g., amphetamine, phenylpropanolamine, and pseudoephedrine) or other stimulants such as methylphenidate No concurrent serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine, sertraline, venlafaxine, nefazodone, mirtazepine, buspirone, and trazodone) or tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, and protriptyline) No concurrent serotonergic agents (e.g., lithium, meperidine, and dextromethorphan) No concurrent active treatment for anemia (e.g., transfusions or epoetin alpha)

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
St. John's wort


Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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