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Beta-Adrenergic Antagonist
Lifestyle and Supportive Care for Multiple Myeloma
N/A
Recruiting
Led By Jens Hillengass
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
Age >= 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of: Module A: ECOG 0 - 1, Module B: ECOG 0 - 2, Module C: ECOG 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 3 months
Awards & highlights
Study Summary
This trial is investigating the effect of adding physical activity, nutritional intervention, and beta blockers to the standard treatment for multiple myeloma. The goal is to improve patient survival outcomes and quality of life.
Who is the study for?
Adults with smoldering multiple myeloma or multiple myeloma who can follow study procedures and have no major comorbidities posing a risk. Participants must consent to the study, use contraception if of child-bearing potential, and meet specific performance status criteria. Exclusions include serious health conditions like heart disease, infections, psychiatric issues that affect compliance, certain dietary restrictions for nutrition module participants, current beta-blocker users or those with contraindications to beta-blockers.Check my eligibility
What is being tested?
The trial is testing non-chemotherapeutic interventions such as physical activity (with necessary equipment), nutritional changes including short-term fasting (excluding diabetics on medication), and the addition of propranolol—a beta-adrenergic antagonist—to standard treatment in newly diagnosed patients before systemic therapy starts. The goal is to see how these interventions impact immune function and quality of life.See study design
What are the potential side effects?
Potential side effects may include typical reactions to increased physical activity or dietary changes such as muscle soreness or digestive discomfort. Propranolol could cause low blood pressure, slow heartbeat, fatigue, dizziness among other symptoms; however individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can care for myself and perform daily activities with little to no difficulty.
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I have been diagnosed with smoldering multiple myeloma or multiple myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in immune cell subsets
Secondary outcome measures
Change in functional status
Changes in anxiety
Changes in body composition
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Module C Group I (propranolol)Experimental Treatment3 Interventions
Patients receive propranolol PO BID for 3 months.
Group II: Module B (intermittent fasting)Experimental Treatment3 Interventions
Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating.
Group III: Module A (strength training, behavioral intervention)Experimental Treatment4 Interventions
Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months.
Group IV: Module C Group II (propranolol)Active Control3 Interventions
Patients continue receiving beta-blocker regimen as per SOC for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Propranolol
2010
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,657 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,950 Patients Enrolled for Multiple Myeloma
Jens HillengassPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
98 Total Patients Enrolled
3 Trials studying Multiple Myeloma
98 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have just been diagnosed with multiple myeloma and have not started treatment.I have a current broken bone or severe muscle system instability that causes symptoms.I am 18 years old or older.My BMI is below 18, indicating malnutrition.I do not have serious health issues that could worsen by joining this study.My doctor thinks I might not be fit for this study due to my health condition or symptoms.I can care for myself and perform daily activities with little to no difficulty.I have been diagnosed with acute bone instability by a CT scan.I have been diagnosed with smoldering multiple myeloma or multiple myeloma.I am diabetic and take medication or insulin to manage it.I do not have conditions that prevent me from using beta-blockers.I am not pregnant and will use birth control during the study.I have a current bone fracture or severe muscle system instability that makes physical activity unsafe.I am currently using or have used a beta blocker in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Module A (strength training, behavioral intervention)
- Group 2: Module B (intermittent fasting)
- Group 3: Module C Group I (propranolol)
- Group 4: Module C Group II (propranolol)
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.
Is enrollment still open for this research trial?
"According to the clinicaltrials.gov, this medical research is presently recruiting participants. It was first released on June 28th 2022 and updated most recently on July 5th 2022."
Answered by AI
How many participants are allowed to join this clinical research project?
"Affirmative. Clinicaltrials.gov confirms that this research, which was initially published on June 28th 2022, is currently searching for participants. Approximately 150 individuals must be enrolled from a single location."
Answered by AI
What are the primary goals of this clinical experiment?
"The principal objective of this trial, tracked over a 12 month period, is to measure the rate of adherence (Selinexor Substudy). Secondary goals involve gauging any changes in stress levels using the Perceived Stress Scale (PSS), body composition via Dexa bone density scans and nutritional behavior before/after intermittent fasting. A GEE logistic model will be used for assessing shifts in dietary habits."
Answered by AI
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