NCT00005805

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

June 2, 2000

Last Update Submit

January 17, 2013

Conditions

Chronic Myeloproliferative DisordersFatigueLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomamonoclonal gammopathy of undetermined significancerecurrent adult Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomachildhood Burkitt lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomastage 0 chronic lymphocytic leukemiaWaldenström macroglobulinemiastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiaunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionpolycythemia veraprimary myelofibrosisessential thrombocythemiauntreated hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiastage II childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I small lymphocytic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage I adult non-Hodgkin lymphomastage II adult non-Hodgkin lymphomastage II small lymphocytic lymphomastage II grade 1 follicular lymphomastage II grade 2 follicular lymphomastage II grade 3 follicular lymphomastage II adult diffuse small cleaved cell lymphomastage II adult diffuse mixed cell lymphomastage II adult diffuse large cell lymphomastage II adult immunoblastic large cell lymphomastage II adult lymphoblastic lymphomastage II adult Burkitt lymphomastage III small lymphocytic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV small lymphocytic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent small lymphocytic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprimary central nervous system non-Hodgkin lymphomafatigueAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaprimary systemic amyloidosisintraocular lymphomastage I mantle cell lymphomacontiguous stage II adult non-Hodgkin lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult non-Hodgkin lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage II mantle cell lymphomamultiple myelomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomastage I marginal zone lymphomastage II marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

St. John's wortDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

    PMID: 36999619DERIVED

MeSH Terms

Conditions

Myeloproliferative DisordersFatigueLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsHodgkin DiseaseMonoclonal Gammopathy of Undetermined SignificanceLymphoma, T-Cell, CutaneousBurkitt LymphomaLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialLeukemia, Hairy CellRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaImmunoglobulin Light-chain AmyloidosisIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal Zone

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesEye NeoplasmsLymphadenopathy

Study Officials

  • David J. Straus, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

July 26, 2004

Study Start

December 1, 1999

Primary Completion

June 1, 2000

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)