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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00670917 |
RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.
PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it works compared with sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Pain Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: acupressure therapy Procedure: biopsy Procedure: bone marrow aspiration Procedure: pain therapy Procedure: questionnaire administration |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
Official Title: | A Randomized Controlled Trial Assessing the Effect of Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to the number of prior bone marrow aspirations and biopsies (BMAB) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs BMAB). Patients are randomized to one of two treatment arms.
Patients in both arms also receive analgesic and anxiolytic medications as determined by the acupressure operator and physician.
Patients complete a questionnaire before and after BMAB to assess pain experienced before and during BMAB and their attitude towards the procedure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Scheduled to undergo a routine bone marrow aspiration with or without biopsy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Principal Investigator: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000594676, JHOC-J07103, JHOC-NA_00013389 |
Study First Received: | May 1, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00670917 |
Health Authority: | Unspecified |
pain unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia |
mast cell leukemia meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia stage II adult T-cell leukemia/lymphoma |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Myelodysplastic syndromes |
Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Myelodysplastic myeloproliferative disease Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin |
Neoplasms Neoplasms by Histologic Type Pathologic Processes Disease |
Immune System Diseases Syndrome Cardiovascular Diseases |