Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
Roswell Park Cancer Institute
Summary
This clinical trial tests the effect of low-intensity mechanical stimulation (LIMS) vibration therapy in patients with hematologic malignancies. Patients with hematologic malignancies often undergo a blood and/or bone marrow transplant (hematopoietic cell transplantation \[HCT\]) or cellular therapy. The LIMS board delivers vibrations through the bones that may stimulate bone growth and may also increase muscle activity and strength and may also increase T-cell activation in patients planning to undergo cellular therapy. LIMS vibration therapy may stop or reverse BMD loss and/or improve the development of T-cells in the body in patients with hematologic malignancies who are undergoing or may plan to undergo HCT or cellular therapies.
Description
PRIMARY OBJECTIVE: I. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT). COHORT 1 II. II. Evaluate chimeric antigen receptors (CAR) T-cell product efficacy of Non-Hodgkin lymphoma (NHL) patients undergoing LIMS in comparison to patients not treated with LIMS. COHORT II SECONDARY OBJECTIVE: I. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT. COHORT 1 II. Evaluate the manufacturing parameters (product viability, total cell dose, transduction efficiency,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * COHORT I: Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible) * COHORT I: Scheduled to undergo an autologous or allogeneic HCT * COHORT 1: \>= 18 years of age * COHORT 1: Patient 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 \- COHORT II: ≥ 18 years of age * COHORT II: Diagnosis of non-Hodgkin lymphoma (specifically diffuse large B-cell lymphoma, follicular lymphoma, m…
Interventions
- ProcedureLow Intensity Vibration Therapy
Undergo LIMS vibration therapy
- ProcedureDual X-ray Absorptiometry
Undergo DEXA scan
- ProcedureBiospecimen Collection
Undergo blood sample collection
Location
- Roswell Park Comprehensive Cancer CenterBuffalo, New York