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

NCT01558778WithdrawnNAINTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Roswell Park Cancer Institute

Enrollment

Start Date

2012-05-01

Completion Date

2012-06-01

Study Type

INTERVENTIONAL

Official Title

Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss

Interventions

management of therapy complicationsmusculoskeletal complications management/prevention

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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 LeukemiaBCR-ABL1 NegativeBlastic Phase Chronic Myelogenous LeukemiaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesDisseminated NeuroblastomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueMyelodysplastic/Myeloproliferative NeoplasmUnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPlasma Cell NeoplasmPoor Prognosis Metastatic Gestational Trophoblastic TumorPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisProlymphocytic LeukemiaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent NeuroblastomaRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaStage II Ovarian Epithelial CancerStage II Ovarian Germ Cell TumorStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Chronic Lymphocytic LeukemiaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Malignant Testicular Germ Cell TumorStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Small Lymphocytic LymphomaStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Breast CancerStage IV Chronic Lymphocytic LeukemiaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Small Lymphocytic Lymphoma

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

Refinement of mechanical stimulation protocol

Best time of day for treatment, staff involvement, etc.

Time frame: From hospital admission to 100 days post-HCT

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