Clinical trial · Interventional

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

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

NCT01558778CI-TRIAL-00007355withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): device not available

Summary

Brief summary (as posted)

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

Conditions

Conditions (103)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Accelerated Phase Chronic Myelogenous Leukemia	Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive	ALIAS	0.90
Adult Acute Lymphoblastic Leukemia in Remission	Adult Acute Lymphoblastic Leukemia	CURATED_BROADER	0.78
Adult Acute Myeloid Leukemia in Remission	Adult Acute Myeloid Leukemia	CURATED_BROADER	0.78
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With Del(5q)	Acute Myeloid Leukemia with del(5q)	ONTOLOGY_EXACT	0.85
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)	Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
management of therapy complications	Procedure	—	UNRESOLVED
musculoskeletal complications management/prevention	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Supportive care (whole body vibration)
description
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).
interventionNames
1. Procedure: management of therapy complications
2. Procedure: musculoskeletal complications management/prevention

Primary outcomes (3)

measure
Refinement of mechanical stimulation protocol
timeFrame
From hospital admission to 100 days post-HCT
description
Best time of day for treatment, staff involvement, etc.
measure
Adherence with treatment
timeFrame
From hospital admission to 100 days post-HCT

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.