Trial record 5 of 38 for:    Open Studies | Plasmacytoma

Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00670917
First received: May 1, 2008
Last updated: April 9, 2010
Last verified: July 2009
  Purpose

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
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Pain
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: acupressure therapy
Procedure: biopsy
Procedure: bone marrow aspiration
Procedure: pain therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial Assessing the Effect of Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Monoclonal Gammopathy of Undetermined Significance Mantle Cell Lymphoma Cutaneous T-cell Lymphoma AL Amyloidosis Polycythemia Vera Essential Thrombocythemia Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Anaplastic Plasmacytoma Systemic Mastocytosis Large Granular Lymphocyte Leukemia
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pain scores before and during bone marrow aspiration and biopsy (BMAB) as measured by a patient-reported 11-point visual analogue pain scale [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit response as measured by duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMAB [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy (BMAB) treated with magnetic acupressure at bilateral large intestine 4 (LI 4) points vs sham acupressure at bilateral proximal fourth interosseus space of the hand.

Secondary

  • To compare the duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMABs.

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.

  • Arm I (acupressure): Patients receive acupressure at bilateral large intestine 4 (LI 4) points using Haci Magnetic Acupressure Suction Cups (MASC) during BMAB.
  • Arm II (sham acupressure): Patients receive acupressure at bilateral proximal fourth interosseus space of the hand using the same size MASC as in arm I during BMAB.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Scheduled to undergo a routine bone marrow aspiration with or without biopsy

    • No requirement for conscious sedation during the procedure

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior acupuncture or acupressure
  • No prior participation in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670917

Locations
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   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00670917     History of Changes
Other Study ID Numbers: CDR0000594676, JHOC-J07103, JHOC-NA_00013389
Study First Received: May 1, 2008
Last Updated: April 9, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
extramedullary plasmacytoma
isolated plasmacytoma of bone
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, BCR-ABL negative
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

Additional relevant MeSH terms:
Plasmacytoma
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Nervous System Neoplasms
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Central Nervous System Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014