Brief 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

Trial Health

At Risk

Trial Health Score

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

Status

withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed

1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed

Last Updated

July 9, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

March 16, 2012

Last Update Submit

July 5, 2012

Conditions

Outcome Measures

Primary Outcomes (3)

Refinement of mechanical stimulation protocol
Best time of day for treatment, staff involvement, etc.
From hospital admission to 100 days post-HCT
Adherence with treatment
From hospital admission to 100 days post-HCT
Effective data collection tools and data points
From hospital admission to 100 days post-HCT

Study Arms (1)

Supportive care (whole body vibration)

EXPERIMENTAL

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 complicationsProcedure: musculoskeletal complications management/prevention

Interventions

management of therapy complicationsPROCEDURE

Undergo mechanical stimulation

Also known as: complications of therapy, management of

Supportive care (whole body vibration)

musculoskeletal complications management/preventionPROCEDURE

Undergo mechanical stimulation

Also known as: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications

Supportive care (whole body vibration)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Roswell Park Cancer Institutelead

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneNeoplasms, Plasma CellPrimary MyelofibrosisLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularTesticular NeoplasmsLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellBreast Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleLeukemia, B-CellBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Philip McCarthy
Roswell Park Cancer Institute
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Last Updated

July 9, 2012

Record last verified: 2012-07

Study Stopped

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Supportive care (whole body vibration)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Supportive care (whole body vibration)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates