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Low-Intensity Vibration Therapy for Bone Density Loss in Blood Cancer Patients
N/A
Recruiting
Led By Megan Herr, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 post -hct
Awards & highlights
Study Summary
This trial tests a therapy to prevent bone density loss in people who get a bone marrow or blood transplant for cancer. The therapy vibrates bones to stimulate growth and improve muscle strength, potentially reducing the risk of fractures and joint replacements.
Who is the study for?
This trial is for adults over 18 who are about to have their first blood or bone marrow transplant for blood cancer treatment. It's open to those with osteoporosis and requires understanding and consent to study procedures. Exclusions include a weight over 275 lbs, BMI under 18, certain medical conditions like joint replacements, history of kidney or gall stones within two years (unless treated), pregnancy, recent fractures without trauma, pacemakers, specific diagnoses like multiple myeloma or amyloidosis, and current heavy anticoagulant use.Check my eligibility
What is being tested?
The trial examines if low-intensity mechanical stimulation (LIMS) vibration therapy can prevent loss of bone density in patients undergoing hematopoietic cell transplantation. LIMS involves standing on a board that sends vibrations through the bones which may stimulate growth and improve muscle strength potentially improving bone mineral density.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from LIMS could include discomfort while using the device, possible aggravation of existing musculoskeletal issues due to vibrations. However, as a non-invasive intervention it is expected to have fewer side effects than pharmacological treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 120 post -hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 post -hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II
time spent on LIMS - Cohort I
Secondary outcome measures
Barriers to LIMS- Cohort 1
Change in femur BMD - Cohort 1
Change in lumbar spine bone mineral density (BMD) - Cohort 1
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: LIMS vibration therapy - Cohort IIExperimental Treatment2 Interventions
Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.
Group II: LIMS vibration Therapy, DEXA Scan - Cohort 1Experimental Treatment3 Interventions
Patients undergo LIMS vibration therapy over 10 minutes on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Dual X-ray Absorptiometry
2015
N/A
~50
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
31,032 Total Patients Enrolled
Megan Herr, MDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on a therapeutic dose of anti-coagulation for a recent clot in my lung or leg.I have been diagnosed with a specific type of non-Hodgkin lymphoma.I have been diagnosed with multiple myeloma or amyloidosis.I had a bone break without injury in the last 60 days.I have had a bone break without any injury.I am scheduled for CAR T-cell therapy in the next 2 months.I have had a stem cell transplant from a donor.I had a brain bleed less than 60 days ago.I have received a cord blood transplant.I cannot or do not want to follow the study rules.I have had an aneurysm in the past.I have received treatment for my condition within the last 60 days.I am 18 years old or older.I have had a total joint replacement.I have had an aneurysm in the past.I am eligible for my first bone marrow transplant.I am scheduled for a stem cell transplant using my own or a donor's cells.I am 18 years old or older.I have had kidney or gall stones in the past 2 years, but no cholecystectomy.I had a brain bleed less than 60 days ago.I weigh at least 275 lbs, suitable for the transplant procedure.I have had a stem cell transplant before and am planning to have another.My weight is at least 275 lbs before a transplant.I had surgery less than 60 days ago.I have previously received CAR T-cell therapy.I am currently on a therapeutic dose of blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: LIMS vibration Therapy, DEXA Scan - Cohort 1
- Group 2: LIMS vibration therapy - Cohort II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment cap for this experiment?
"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is currently seeking volunteers; it was originally posted July 15th 2023 and last updated June 23rd 2023. The study requires 50 participants from a single location."
Answered by AI
Are there openings available for participation in this trial currently?
"According to the information present on clinicaltrials.gov, this trial is currently seeking volunteers for participation and has been since July 15th 2023. The post was last modified on June 23rd of the same year."
Answered by AI
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