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Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant

This study has been withdrawn prior to enrollment.
(device not available)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558778
First Posted: March 20, 2012
Last Update Posted: July 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose
This pilot clinical trial studies mechanical stimulation in preventing bone density loss in patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or reverse bone loss, increase muscle and cardiac performance, and improve overall health

Condition Intervention
Accelerated Phase Chronic Myelogenous 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 Del(5q) 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-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia de Novo Myelodysplastic Syndromes Disseminated Neuroblastoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Plasma Cell Neoplasm Poor Prognosis Metastatic Gestational Trophoblastic Tumor Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Neuroblastoma Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Splenic Marginal Zone Lymphoma Stage II Ovarian Epithelial Cancer Stage II Ovarian Germ Cell Tumor Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Malignant Testicular Germ Cell Tumor Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Ovarian Epithelial Cancer Stage III Ovarian Germ Cell Tumor Stage III Small Lymphocytic Lymphoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Breast Cancer Stage IV Chronic Lymphocytic Leukemia Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor Stage IV Small Lymphocytic Lymphoma Procedure: management of therapy complications Procedure: musculoskeletal complications management/prevention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Refinement of mechanical stimulation protocol [ Time Frame: From hospital admission to 100 days post-HCT ]
    Best time of day for treatment, staff involvement, etc.

  • Adherence with treatment [ Time Frame: From hospital admission to 100 days post-HCT ]
  • Effective data collection tools and data points [ Time Frame: From hospital admission to 100 days post-HCT ]

Enrollment: 0
Study Start Date: May 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (whole body vibration)
Patients undergo mechanical stimulation over 20 minutes QD beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).
Procedure: management of therapy complications
Undergo mechanical stimulation
Other Name: complications of therapy, management of
Procedure: musculoskeletal complications management/prevention
Undergo mechanical stimulation
Other Names:
  • complications management/prevention, musculoskeletal
  • management/prevention, musculoskeletal complications

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.

SECONDARY OBJECTIVES:

I. To evaluate the data collection tools to prepare for a larger phase II trial.

OUTLINE:

Patients undergo mechanical stimulation over 20 minutes once daily (QD) beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
  • Pre-transplant Karnofsky Performance Status (KPS) >= 70
  • Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Any prior allogeneic HCT
  • Pre-transplant weight >= 280 lbs
  • Body mass index (BMI) < l8kg/m^2
  • Human leukocyte antigen (HLA)-mismatched HCT
  • Cord blood transplant
  • Osteopenia or osteoporosis (T-score =< -1.0)
  • Multiple myeloma diagnosis
  • Any prior history of a central nervous system (CNS) hemorrhage
  • Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
  • Current or previous bisphosphonate use
  • Prior history of non-traumatic fracture
  • Any screws, pins, rods, or other metal objects in the body
  • Total joint replacement
  • History of kidney stones or gall stones
  • Any artificial limbs
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01558778


Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Philip McCarthy Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01558778     History of Changes
Other Study ID Numbers: I 190510
NCI-2011-02354 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 16, 2012
First Posted: March 20, 2012
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Breast Neoplasms
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Follicular
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Neoplasm Metastasis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Neuroblastoma
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Mycoses
Primary Myelofibrosis