St. John's Wort in Relieving Fatigue in Patients Undergoing Chemotherapy or Hormone Therapy for Cancer
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ClinicalTrials.gov Identifier: NCT00005805 |
Recruitment Status :
Completed
First Posted : July 26, 2004
Last Update Posted : January 18, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Fatigue Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Dietary Supplement: St. John's wort | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Primary Purpose: | Supportive Care |
Official Title: | Does Hypericum Reduce Fatigue in Cancer Patients on Chemotherapy? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
Study Start Date : | December 1999 |
Actual Primary Completion Date : | June 2000 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005805
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | David J. Straus, MD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00005805 |
Other Study ID Numbers: |
99-102 MSKCC-99102 NCI-G00-1772 |
First Posted: | July 26, 2004 Key Record Dates |
Last Update Posted: | January 18, 2013 |
Last Verified: | January 2013 |
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent adult Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma childhood Burkitt lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma |
stage 0 chronic lymphocytic leukemia Waldenström macroglobulinemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia unspecified adult solid tumor, protocol specific |
Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Precancerous Conditions Myelodysplastic Syndromes Myeloproliferative Disorders Syndrome Fatigue Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases |