- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05312255
Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
Improving Host Factors in Patients With Monoclonal Gammopathies
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma cell disorders.
SECONDARY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness in patients with monoclonal plasma cell disorders.
II. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effect reduction) on parameters of stress, mental health and quality of life in patients with monoclonal plasma cell disorders.
OUTLINE: Patients are assigned to Module A, B or C.
MODULE A: 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.
MODULE B: 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.
MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group 2 (current taking beta-blockers).
GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months.
GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for 3 months.
After completion of the study interventions, patients in module A are followed every 3 months for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are followed for 3 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Jens Hillengass
- Phone Number: 716-845-3863
- Email: Jens.Hillengass@roswellpark.org
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Principal Investigator:
- Jens Hillengass
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Have a diagnosis of smoldering multiple myeloma or multiple myeloma
- Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
- Are able to understand and follow assessment and intervention procedures
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- MODULE A (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
- MODULE B (NUTRITION): Not applicable
- MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy
- MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Exclusion Criteria:
- Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)
- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable.
- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
- MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon
- MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18)
- MODULE B (NUTRITION): Special diets (physician prescribed)
- MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin
- MODULE B (NUTRITION): Other reasons not to withhold food
- MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption
- MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment
- MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
- MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Module A (strength training, behavioral intervention)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Wear a FitBit device and receive prompts for 6 months
Other Names:
Undergo strength training for 6 months
Other Names:
|
Experimental: Module B (intermittent fasting)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Participate in intermittent fasting
Other Names:
|
Experimental: Module C Group I (propranolol)
Patients receive propranolol PO BID for 3 months.
|
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
|
Active Comparator: Module C Group II (propranolol)
Patients continue receiving beta-blocker regimen as per SOC for 3 months.
|
Ancillary studies
Other Names:
Ancillary studies
Receive beta-blocker regimen as per SOC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in immune cell subsets
Time Frame: At baseline and at 1 year
|
Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy).
Will use a linear mixed model.
Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test.
With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD).
|
At baseline and at 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the gut microbiome
Time Frame: At 1 and 3 months
|
Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting).
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At 1 and 3 months
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Comparison in bone markers
Time Frame: At 1 and 3 months
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Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.
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At 1 and 3 months
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Changes in body composition
Time Frame: 3 months
|
Dexa (bone density scan) will be performed at 1 and 3 months
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3 months
|
Changes in stress
Time Frame: At 1 and 3 months
|
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month.
The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale.
The scale minimum total score is 0, the maximum is 40.
Higher total scores indicate a worse outcome
|
At 1 and 3 months
|
Changes in anxiety
Time Frame: At 1 and 3 months
|
As assessed by the Generalized Anxiety Disorder 7-item Scale
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At 1 and 3 months
|
Changes in fatigue as assessed by EORTC-LQLQ-FA12
Time Frame: At 1 and 3 months
|
12-item multidimensional fatigue questionnaire.The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much").
The range is 3.
For the raw score, less points are considered to have a better outcome.
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At 1 and 3 months
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Change in functional status
Time Frame: At 1 and 3 months
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basic assessment of physical activity before diagnosis will be compared to one administered at follow up
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At 1 and 3 months
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Changes in nutritional behavior before and after intermittent fasting
Time Frame: Up to 5 months
|
Will be modeled using a GEE logistic model.
Rates of positive nutritional behavior will be compared beween time points.
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Up to 5 months
|
Changes in stress-related biomarkers
Time Frame: Up to 6 months
|
Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.
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Up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Hillengass, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Hypergammaglobulinemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Smoldering Multiple Myeloma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
- Adrenergic Agents
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
Other Study ID Numbers
- I 1680221 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2022-01918 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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