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

Roswell Park Comprehensive Cancer Center

Status: Withdrawn

Conditions: Stage IIIA Breast Cancer; Stage III Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Chronic Neutrophilic Leukemia; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Recurrent Ovarian Germ Cell Tumor; Noncontiguous Stage II Mantle Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Stage III Grade 3 Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Chronic Myelomonocytic Leukemia; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Stage III Adult Diffuse Large Cell Lymphoma; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Ovarian Epithelial Cancer; Recurrent Malignant Testicular Germ Cell Tumor; Stage III Marginal Zone Lymphoma; Refractory Hairy Cell Leukemia; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage IV Adult Hodgkin Lymphoma; Stage IIIB Breast Cancer; Stage III Ovarian Epithelial Cancer; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Recurrent Adult Lymphoblastic Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Poor Prognosis Metastatic Gestational Trophoblastic Tumor; Stage IV Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Secondary Myelodysplastic Syndromes; Disseminated Neuroblastoma; Stage IV Ovarian Germ Cell Tumor; Stage IV Adult Burkitt Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage II Ovarian Epithelial Cancer; Recurrent Adult Acute Myeloid Leukemia; Stage IV Small Lymphocytic Lymphoma; Recurrent Neuroblastoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Splenic Marginal Zone Lymphoma; Chronic Eosinophilic Leukemia; Noncontiguous Stage II Marginal Zone Lymphoma; Adult Acute Myeloid Leukemia in Remission; Stage IV Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Stage III Chronic Lymphocytic Leukemia; Plasma Cell Neoplasm; Stage III Adult Immunoblastic Large Cell Lymphoma; Recurrent Small Lymphocytic Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Accelerated Phase Chronic Myelogenous Leukemia; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Noncontiguous Stage II Adult Burkitt Lymphoma; Chronic Phase Chronic Myelogenous Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Recurrent Adult Hodgkin Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Previously Treated Myelodysplastic Syndromes; Relapsing Chronic Myelogenous Leukemia; Recurrent Adult Diffuse Mixed Cell Lymphoma; Refractory Chronic Lymphocytic Leukemia; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Stage IIIC Breast Cancer; Stage IV Grade 3 Follicular Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Ovarian Germ Cell Tumor; Prolymphocytic Leukemia; Adult Acute Myeloid Leukemia With Del(5q); Stage III Malignant Testicular Germ Cell Tumor; de Novo Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Adult Acute Lymphoblastic Leukemia in Remission; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Noncontiguous Stage II Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Primary Myelofibrosis; Secondary Acute Myeloid Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Breast Cancer

Treatments: Procedure: management of therapy complications; Procedure: musculoskeletal complications management/prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT01558778

NCI-2011-02354 (Registry Identifier)

I 190510

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (whole body vibration)

Experimental group

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).

Treatment:

Procedure: musculoskeletal complications management/prevention

Procedure: management of therapy complications